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HomeCompaniesHbap Fa Us1 Oraclecloud Com CX 1QC Specialist III/IV

QC Specialist III/IV

Hbap Fa Us1 Oraclecloud Com CX 1 · Wilmington, OH, United States · On Site · Active · Oracle Recruiting Cloud / Fusion HCM

Job facts

FieldValue
CompanyHbap Fa Us1 Oraclecloud Com CX 1
TitleQC Specialist III/IV
Normalized title-
Department / teamQuality
LocationWilmington, OH, United States
Work modelOn Site
Employment typeFull Time
Salary-
Statusactive
ATS providerOracle Recruiting Cloud / Fusion HCM
Posted / first seen2026-06-04 / 2026-06-06
Changed / last seen2026-06-06 / 2026-06-06

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Linked records

CompanyHbap Fa Us1 Oraclecloud Com CX 1
Sourcec9a1af55-d1aa-41d7-bb8e-0bf8dc082d85
ATS providerOracle Recruiting Cloud / Fusion HCM

Description

Description GENERAL DESCRIPTION: The Quality Control QC SPECIALIST III/IV is responsible for lifecycle management, compliance, and performance of analytical instrumentation used within Quality Control laboratories. This role serves as a technical expert, ensuring instrument qualification, calibration, maintenance, troubleshooting, and data integrity meet regulatory expectations (FDA, ICH, JP). MAJOR RESPONSIBILITIES Instrumentation Management Oversee lifecycle management of chemistry or microbiology laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, or TOCs, Particle Counters, MAS-100 Viable Air Sampler, respectively, and other analytical platforms Lead installation, qualification, and validation (IQ/OQ/PQ) activities in compliance with regulatory guidelines Ensure instruments remain in a validated state through periodic calibration, preventive maintenance, and requalification activities Manage instrument asset tracking systems and documentation. Compliance & Data Integrity Support Risk assessments to ensure all instrumentation, software, and data systems comply with Alkermes, data governance policy and data integrity principles (ICH Q9) Develop, review, and approve SOPs, protocols, and reports related to instrumentation. Support internal audits, client audits, and regulatory inspections Support Investigations, deviations, out-of-specification (OOS), and out-of-trend (OOT) results associated with instrumentation Technical Expertise & Troubleshooting May serve as SME or support the SME for complex instrument troubleshooting, root cause analysis, and resolution of technical issues Coordinate with vendors for instrument repairs, upgrades, and service contracts Support the evaluation and implementation of new technologies, software, and analytical tools. Support method transfers from an instrument qualification perspective Project Leadership Lead or support cross-functional projects such as lab expansions, new equipment implementation, and digital transformation initiatives Drive continuous improvement initiatives to enhance lab efficiency, reliability, and compliance. Manage change control processes related to instrumentation and systems Documentation & Systems Management Maintain accurate and complete records for calibration, maintenance, qualification, and deviations Oversee computerized systems validation (CSV) for laboratory instruments and software platforms Support other groups to ensure proper configuration and compliance of laboratory data systems (e.g., Empower, LIMS). Training & Mentorship Train and mentor other QC specialists on instrument operation, troubleshooting, and compliance requirements May train and mentor QC analysts, as requested Serve as a resource for best practices in laboratory instrumentation SKILLS/COMPETENCIES Deep knowledge of instrument qualification and validation (IQ/OQ/PQ) Strong understanding of data integrity and compliance regulations Excellent troubleshooting and root cause analysis skills Experience with laboratory software (e.g., Empower, LIMS, CDS systems) Experience with Maximo Strong documentation and technical writing abilities Project management and leadership capability Effective communication and cross-functional collaboration PERSONAL ATTRIBUTES Ability to work hard and contribute to an enjoyable rapidly changing working environment Proactively achieves results for the best of the organization Willingness to learn new things Commitment to teamwork Commitment to continuous improvement in all areas Ability to focus attention to details and ensure high quality work Ability to work safely; seek out and encourage safe practices Takes input from others and stimulates open discussions Excellent communication and documentation skills EDUCATION/EXPERIENCE: QC SPECIALIST III Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or Masters Degree in Chemistry with approx. 2 years of laboratory experience QC SPECIALIST IV Bachelors Degree in Chemistry with approx. 5 years of laboratory experience or Masters Degree in Chemistry with approx. 3 years of laboratory experience #LI-RS1 #LI-Onsite Company Why join Team Alkermes? Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders. We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

Full job record

Job ID8ae2bdf92bd989fbb324cae5f6e83a2ac6934f7c
Org IDd831e3c2-6a79-44af-a2cf-903b76ab4731
Source IDc9a1af55-d1aa-41d7-bb8e-0bf8dc082d85
Board IDc9a1af55-d1aa-41d7-bb8e-0bf8dc082d85
Provideroracle_hcm
Provider Job Key14004
TitleQC Specialist III/IV
Normalized Title
Statusactive
Activeyes
Location TextWilmington, OH, United States
DepartmentQuality
Team
Employment Typefull_time
Workplace Typeon_site
Remote Policy
CountryUnited States
RegionOH
CityWilmington
Salary RawDescription GENERAL DESCRIPTION: The Quality Control QC SPECIALIST III/IV is responsible for lifecycle management, compliance, and performance of analytical instrumentation used within Quality Control laboratories. This role serves as a technical expert, ensuring instrument qualification, calibration, maintenance, troubleshooting, and data integrity meet regulatory expectations (FDA, ICH, JP). MAJOR RESPONSIBILITIES Instrumentation Management Oversee lifecycle management of chemistry or microbiology laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, or TOCs, Particle Counters, MAS-100 Viable Air Sampler, respectively, and other analytical platforms Lead installation, qualification, and validation (IQ/OQ/PQ) activities in compliance with regulatory guidelines Ensure instruments remain in a validated state through periodic calibration, preventive maintenance, and requalification activities Manage instrument asset tracking systems and documentation. Compliance & Data Integrity Support Risk assessments to ensure all instrumentation, software, and data systems comply with Alkermes, data governance policy and data integrity principles (ICH Q9) Develop, review, and approve SOPs, protocols, and reports related to instrumentation. Support internal audits, client audits, and regulatory inspections Support Investigations, deviations, out-of-specification (OOS), and out-of-trend (OOT) results associated with instrumentation Technical Expertise & Troubleshooting May serve as SME or support the SME for complex instrument troubleshooting, root cause analysis, and resolution of technical issues Coordinate with vendors for instrument repairs, upgrades, and service contracts Support the evaluation and implementation of new technologies, software, and analytical tools. Support method transfers from an instrument qualification perspective Project Leadership Lead or support cross-functional projects such as lab expansions, new equipment implementation, and digital transformation initiatives Drive continuous improvement initiatives to enhance lab efficiency, reliability, and compliance. Manage change control processes related to instrumentation and systems Documentation & Systems Management Maintain accurate and complete records for calibration, maintenance, qualification, and deviations Oversee computerized systems validation (CSV) for laboratory instruments and software platforms Support other groups to ensure proper configuration and compliance of laboratory data systems (e.g., Empower, LIMS). Training & Mentorship Train and mentor other QC specialists on instrument operation, troubleshooting, and compliance requirements May train and mentor QC analysts, as requested Serve as a resource for best practices in laboratory instrumentation SKILLS/COMPETENCIES Deep knowledge of instrument qualification and validation (IQ/OQ/PQ) Strong understanding of data integrity and compliance regulations Excellent troubleshooting and root cause analysis skills Experience with laboratory software (e.g., Empower, LIMS, CDS systems) Experience with Maximo Strong documentation and technical writing abilities Project management and leadership capability Effective communication and cross-functional collaboration PERSONAL ATTRIBUTES Ability to work hard and contribute to an enjoyable rapidly changing working environment Proactively achieves results for the best of the organization Willingness to learn new things Commitment to teamwork Commitment to continuous improvement in all areas Ability to focus attention to details and ensure high quality work Ability to work safely; seek out and encourage safe practices Takes input from others and stimulates open discussions Excellent communication and documentation skills EDUCATION/EXPERIENCE: QC SPECIALIST III Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or Masters Degree in Chemistry with approx. 2 years of laboratory experience QC SPECIALIST IV Bachelors Degree in Chemistry with approx. 5 years of laboratory experience or Masters Degree in Chemistry with approx. 3 years of laboratory experience #LI-RS1 #LI-Onsite Company Why join Team Alkermes? Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders. We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Salary Min
Salary Max
Salary Currency
Salary Period
Source URLhttps://hbap.fa.us1.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/14004
Apply URLhttps://hbap.fa.us1.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1/job/14004
First Seen At2026-06-06 11:11:22Z
Last Seen At2026-06-06 11:11:22Z
Last Checked At2026-06-06 11:11:22Z
Last Changed At2026-06-06 11:11:22Z
Inactive At
Source Posted At2026-06-04 13:26:10Z
Source Updated At
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    "ExternalDescriptionStr": "<p align=\"left\" style=\"text-align: left;\">GENERAL DESCRIPTION:</p><p align=\"left\" style=\"text-align: left;\">The Quality Control QC SPECIALIST III/IV is responsible for lifecycle management, compliance, and performance of analytical instrumentation used within Quality Control laboratories. This role serves as a technical expert, ensuring instrument qualification, calibration, maintenance, troubleshooting, and data integrity meet regulatory expectations (FDA, ICH, JP).</p><p align=\"left\" style=\"text-align: left;\">&nbsp;</p><p>MAJOR RESPONSIBILITIES</p><p>Instrumentation Management</p><ul style=\"list-style-type: disc; padding-left: 30px;\"><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Oversee lifecycle management of chemistry or microbiology laboratory instruments, including HPLC, UPLC, GC, LC-MS, UV-Vis, FTIR, dissolution systems, or TOCs, Particle Counters, MAS-100 Viable Air Sampler, respectively, and other analytical platforms</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Lead installation, qualification, and validation (IQ/OQ/PQ) activities in compliance with regulatory guidelines</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Ensure instruments remain in a validated state through periodic calibration, preventive maintenance, and requalification activities</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Manage instrument asset tracking systems and documentation.</p></li></ul><p align=\"left\" style=\"text-align: left;\">&nbsp;</p><p align=\"left\" style=\"margin-bottom: 6pt; text-align: left;\">Compliance &amp; Data Integrity</p><ul style=\"list-style-type: disc; padding-left: 30px;\"><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Support Risk assessments to ensure all instrumentation, software, and data systems comply with Alkermes, data governance policy and data integrity principles (ICH Q9)&nbsp;</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Develop, review, and approve SOPs, protocols, and reports related to instrumentation.</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Support internal audits, client audits, and regulatory inspections</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Support Investigations, deviations, out-of-specification (OOS), and out-of-trend (OOT) results associated with instrumentation</p></li></ul><p align=\"left\" style=\"text-align: left;\">&nbsp;</p><p align=\"left\" style=\"margin-bottom: 6pt; margin-right: 0in; margin-top: 0in; text-align: left;\">Technical Expertise &amp; Troubleshooting</p><ul style=\"list-style-type: disc; padding-left: 30px;\"><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">May serve as SME or support the SME for complex instrument troubleshooting, root cause analysis, and resolution of technical issues</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Coordinate with vendors for instrument repairs, upgrades, and service contracts</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Support the evaluation and implementation of new technologies, software, and analytical tools.</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Support method transfers from an instrument qualification perspective</p><p align=\"left\" style=\"text-align: left;\">&nbsp;</p></li></ul><p align=\"left\" style=\"margin-bottom: 6pt; margin-right: 0in; margin-top: 0in; text-align: left;\">&nbsp;</p><p align=\"left\" style=\"margin-bottom: 6pt; margin-right: 0in; margin-top: 0in; text-align: left;\">Project Leadership</p><ul style=\"list-style-type: disc; padding-left: 30px;\"><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Lead or support cross-functional projects such as lab expansions, new equipment implementation, and digital transformation initiatives</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Drive continuous improvement initiatives to enhance lab efficiency, reliability, and compliance.</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Manage change control processes related to instrumentation and systems</p><p align=\"left\" style=\"text-align: left;\">&nbsp;</p></li></ul><p align=\"left\" style=\"margin-bottom: 6pt; margin-right: 0in; margin-top: 0in; text-align: left;\">&nbsp;</p><p align=\"left\" style=\"margin-bottom: 6pt; margin-right: 0in; margin-top: 0in; text-align: left;\">Documentation &amp; Systems Management</p><ul style=\"list-style-type: disc; padding-left: 30px;\"><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Maintain accurate and complete records for calibration, maintenance, qualification, and deviations</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Oversee computerized systems validation (CSV) for laboratory instruments and software platforms</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Support other groups to ensure proper configuration and compliance of laboratory data systems (e.g., Empower, LIMS).</p></li></ul><p align=\"left\" style=\"text-align: left;\">&nbsp;</p><p align=\"left\" style=\"margin-bottom: 6pt; text-align: left;\">Training &amp; Mentorship</p><ul style=\"list-style-type: disc; padding-left: 30px;\"><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Train and mentor other QC specialists on instrument operation, troubleshooting, and compliance requirements</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">May train and mentor QC analysts, as requested&nbsp;</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Serve as a resource for best practices in laboratory instrumentation</p></li></ul><p align=\"left\" style=\"text-align: left;\">&nbsp;</p><p align=\"left\" style=\"margin-bottom: 6pt; margin-right: 15.1pt; margin-top: 0in; text-align: left;\">SKILLS/COMPETENCIES</p><ul style=\"list-style-type: disc; padding-left: 24px;\"><li>Deep knowledge of instrument qualification and validation (IQ/OQ/PQ)</li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Strong understanding of data integrity and compliance regulations</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Excellent troubleshooting and root cause analysis skills</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Experience with laboratory software (e.g., Empower, LIMS, CDS systems)</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Experience with Maximo</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Strong documentation and technical writing abilities</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Project management and leadership capability</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Effective communication and cross-functional collaboration</p><p align=\"left\" style=\"text-align: left;\">&nbsp;</p><p align=\"left\" style=\"text-align: left;\">&nbsp;</p></li></ul><p align=\"left\" style=\"text-align: left;\">PERSONAL ATTRIBUTES</p><ul style=\"list-style-type: disc; padding-left: 24px;\"><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Ability to work hard and contribute to an enjoyable rapidly changing working environment</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Proactively achieves results for the best of the organization</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Willingness to learn new things</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Commitment to teamwork</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Commitment to continuous improvement in all areas</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Ability to focus attention to details and ensure high quality work</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Ability to work safely; seek out and encourage safe practices</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Takes input from others and stimulates open discussions</p></li><li class=\"ortl-align-left\"><p align=\"left\" style=\"line-height: 13.5pt; text-align: left;\">Excellent communication and documentation skills</p></li></ul><p>&nbsp;</p><p>EDUCATION/EXPERIENCE:</p><p>QC SPECIALIST III&nbsp;</p><ul style=\"list-style-type: disc; padding-left: 24px;\"><li>Bachelors Degree in Chemistry with approx. 3-4 years of laboratory experience or</li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Masters Degree in Chemistry with approx. 2 years of laboratory experience</p></li></ul><p align=\"left\" style=\"text-align: left;\">&nbsp;</p><p align=\"left\" style=\"text-align: left;\">QC SPECIALIST IV</p><ul style=\"list-style-type: disc; padding-left: 24px;\"><li>Bachelors Degree in Chemistry with approx. 5 years of laboratory experience or</li><li class=\"ortl-align-left\"><p align=\"left\" style=\"text-align: left;\">Masters Degree in Chemistry with approx. 3 years of laboratory experience</p></li></ul><p align=\"left\" style=\"text-align: left;\">&nbsp;</p><p align=\"left\" style=\"text-align: left;\">#LI-RS1</p><p align=\"left\" style=\"text-align: left;\">#LI-Onsite</p>",
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      }
    ],
    "LegalEmployer": null,
    "MediaThumbURL": null,
    "WorkplaceType": "",
    "BusinessUnitId": 100000000170392,
    "OrganizationId": 300000155417084,
    "PostingEndDate": null,
    "LegalEmployerId": 300000001067001,
    "PrimaryLocation": "Wilmington, OH, United States",
    "WorkDurationYears": null,
    "WorkplaceTypeCode": null,
    "BeFirstToApplyFlag": false,
    "WorkDurationMonths": null,
    "otherWorkLocations": [],
    "secondaryLocations": [],
    "ShortDescriptionStr": "",
    "requisitionFlexFields": [],
    "DomesticTravelRequired": null,
    "PrimaryLocationCountry": "US",
    "ExternalQualificationsStr": null,
    "ExternalResponsibilitiesStr": null,
    "InternationalTravelRequired": null
  },
  "detail_meta": {
    "url": "https://hbap.fa.us1.oraclecloud.com/hcmRestApi/resources/latest/recruitingCEJobRequisitionDetails?expand=all&onlyData=true&finder=ById;Id=%2214004%22,siteNumber=CX_1",
    "http_status": 200,
    "content_type": "application/json",
    "response_bytes": 14668
  },
  "detail_errors": []
}
Get this page with API

Rendered from the bluedoor Job Postings API. Reproduce it:

GET https://api.bluedoor.sh/job-postings/v1/jobs/8ae2bdf92bd989fbb324cae5f6e83a2ac6934f7c?include=descriptionJSON
GET https://api.bluedoor.sh/job-postings/v1/orgs/d831e3c2-6a79-44af-a2cf-903b76ab4731JSON
GET https://api.bluedoor.sh/job-postings/v1/sources/c9a1af55-d1aa-41d7-bb8e-0bf8dc082d85JSON
GET https://api.bluedoor.sh/job-postings/v1/jobs/8ae2bdf92bd989fbb324cae5f6e83a2ac6934f7c/eventsJSON