Quality Assurance Specialist I

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    "ShortDescriptionStr": "The Quality Assurance Specialist I is a key contributor in upholding product quality, patient safety, and customer trust. This role maintains quality systems and provides a strong on-the-floor presence within manufacturing, ensuring operations are performed in alignment with regulatory requirements, internal standards, and Curia’s commitment to doing work the right way.",
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    "ExternalDescriptionStr": "<p><span><strong>Quality Assurance Specialist I in Springfield, MO</strong></span></p>\n<p><span>Build your future at Curia, where our work has the power to save lives&nbsp;</span></p>\n<p><span>Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients.&nbsp;</span><span>At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.</span></p>\n<p><span><strong>We proudly offer</strong></span></p>\n<ul>\n <li><span>Generous benefit options (eligible first day of employment)&nbsp;</span></li>\n <li><span>Paid training, vacation and holidays (vacation accrual begins on first day of employment)</span></li>\n <li><span>Career advancement opportunities&nbsp;</span></li>\n <li><span>Education reimbursement</span></li>\n <li><span>401K program with matching contributions</span></li>\n <li><span>Learning platform</span></li>\n <li><span>And more!&nbsp;</span></li>\n</ul>\n<p>The Quality Assurance Specialist I is a key contributor in upholding product quality, patient safety, and customer trust. This role maintains quality systems and provides a strong on-the-floor presence within manufacturing, ensuring operations are performed in alignment with regulatory requirements, internal standards, and Curia’s commitment to doing work the right way.</p>\n<p>With a focus on Curiosity, Urgency, Respect, Integrity, and Accountability, the Quality Assurance Specialist I proactively identifies compliance risks before and during manufacturing activities, helping prevent deviations whenever possible. When issues arise, this role acts with urgency and ownership to support immediate corrective actions, ensuring they are clearly documented, traceable, and aligned with cGMP and internal procedures.</p>\n<p>Working primarily in cGMP production environments, the Specialist partners closely with manufacturing teams to reinforce adherence to the quality system, initiate and support deviation processes, and contribute to timely, effective resolution. Through consistent presence, attention to detail, and collaboration, this role helps build a culture where quality and compliance are embedded in every step of the process.</p>\n<p><strong>Core Responsibilities</strong></p>\n<p>Quality &amp; Compliance Oversight</p>\n<ul>\n <li>Provide on-the-floor QA presence as needed to ensure manufacturing activities are performed in alignment with cGMP requirements, site procedures, and regulatory expectations&nbsp;</li>\n <li>Monitor and reinforce adherence to SOPs, batch records, protocols, change controls, and other controlled documents&nbsp;</li>\n <li>Identify, escalate, and help address quality risks in real time, partnering with teams to implement compliant solutions&nbsp;</li>\n <li>Represent Quality Assurance in situations requiring immediate corrective action, ensuring actions taken are appropriate and properly documented</li>\n</ul>\n<p>Documentation &amp; Good Documentation Practices (GDP)</p>\n<ul>\n <li>Review batch records and quality documentation to ensure accuracy, completeness, and compliance with ALCOA++ and site standards&nbsp;</li>\n <li>Maintain and support quality documentation systems, including archival, scanning, and controlled document management&nbsp;</li>\n <li>Author, review, and/or support approval of Quality Management System documents such as SOPs, deviations, CAPAs, and change controls</li>\n</ul>\n<p>Deviation Management &amp; Continuous Improvement</p>\n<ul>\n <li>Initiate, track, and support the resolution of deviations, investigations, change controls, and CAPAs&nbsp;</li>\n <li>Assist with root cause investigations and ensure documentation supports clear, traceable outcomes&nbsp;</li>\n <li>Contribute to the development and maintenance of quality metrics for management review&nbsp;</li>\n <li>Solicit cross-functional feedback to identify opportunities for operational and quality improvements</li>\n</ul>\n<p>Audits, Inspections &amp; Readiness</p>\n<ul>\n <li>Perform and/or support internal audits, walkthroughs, and external inspections&nbsp;</li>\n <li>Conduct QA visual inspection activities as required&nbsp;</li>\n <li>Help ensure the site remains inspection-ready through consistent application of quality standards</li>\n</ul>\n<p>Training, Collaboration &amp; Development</p>\n<ul>\n <li>Provide guidance and support to team members on cGMP requirements, SOPs, and documentation practices&nbsp;</li>\n <li>Maintain current training in cGMP and applicable regulatory requirements&nbsp;</li>\n <li>Collaborate with manufacturing and cross-functional teams to promote a culture of quality, accountability, and continuous learning&nbsp;</li>\n <li>Continue building knowledge of regulatory expectations and quality systems in a fast-paced environment</li>\n</ul>\n<p><strong>Education, experience, certification and licensures: Required</strong></p>\n<ul>\n <li>Bachelor’s degree in Life Science or related field</li>\n <li>Minimum 0-3 years’ experience in a cGMP and FDA-regulated industry</li>\n</ul>\n<p><strong>Preferred</strong></p>\n<ul>\n <li>Excellent verbal and written communication skills</li>\n <li>Focused self-starter with attention to detail</li>\n <li>Team-oriented, but able to work independently and proactively</li>\n <li>Ability to multi-task</li>\n <li>Strong problem solving and organizational skills</li>\n <li>Strong critical thinking skills, including familiarity with root-cause analysis</li>\n</ul>\n<p><strong>Physical requirements</strong></p>\n<p>While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.</p>\n<p><strong>Work environment</strong></p>\n<ul>\n <li>While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate.</li>\n <li>Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.</li>\n</ul>\n<p><span>The statements above describe the general nature and level of work performed in this role and are not intended to be an exhaustive list of all responsibilities. Management reserves the right to modify or assign additional duties as needed.</span></p>\n<p><span>To be successful in this role, an individual must be able to perform the essential functions of the job satisfactorily. The requirements outlined reflect the knowledge, skills, abilities, physical demands, and work environment associated with the position. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.</span></p>\n<p><span><strong>Other Qualifications</strong></span></p>\n<ul>\n <li><span>Must pass a background check</span></li>\n <li><span>Must pass a drug screen</span></li>\n <li><span>May be required to pass Occupational Health Screening</span></li>\n</ul>\n<p><span><i>Education, experience, location and tenure may be considered along with internal equity when job offers are extended.</i></span></p>\n<p><span>We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.</span></p>\n<p><span>All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer.&nbsp;All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.</span></p>",
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