Manager, Quality Assurance

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    "ExternalDescriptionStr": "<p><span><strong>Manager, Quality Assurance 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><span>At Curia, quality is more than compliance — it is how we deliver on our promise to customers and the patients they serve. The <strong>Quality Assurance Manager</strong> plays a key role in ensuring products are manufactured in accordance with Curia’s quality systems, regulatory requirements, and customer expectations.</span></p>\n<p><span>This role partners closely with the Director, Quality Assurance and cross-functional teams to implement and continuously improve quality processes, including in-process and final product inspections, ensuring materials consistently meet defined standards for safety, reliability, and performance.</span></p>\n<p><span>The <strong>Quality Assurance Manager</strong> helps drive a culture of accountability and quality across the site by strengthening systems, addressing issues with urgency, and ensuring teams are equipped to deliver high-quality outcomes every day.</span></p>\n<p><span><strong>MAJOR DUTIES AND RESPONSIBILITIES </strong><i><strong>include the following.&nbsp; Other duties may be assigned.</strong></i></span></p>\n<p><span><strong>Lead Quality with Accountability and Integrity</strong></span></p>\n<ul>\n <li><span>Partner with the Site Quality Head to strengthen and sustain the site Quality Assurance program.&nbsp;</span></li>\n <li><span>Own batch review and product disposition decisions, ensuring compliance with internal standards and regulatory requirements.&nbsp;</span></li>\n <li><span>Make sound, timely decisions that protect product quality and patient safety.&nbsp;</span></li>\n</ul>\n<p><span><strong>Drive Compliance Through Strong Systems</strong></span></p>\n<ul>\n <li><span>Develop and continuously improve quality standards, procedures, and systems that support manufacturing and support functions.&nbsp;</span></li>\n <li><span>Ensure effective document and change control processes, with clear and compliant implementation across the site.&nbsp;</span></li>\n <li><span>Maintain inspection readiness by ensuring quality records and systems are accurate, complete, and audit-ready.&nbsp;</span></li>\n</ul>\n<p><span><strong>Approach Problems with Curiosity and Rigor</strong></span></p>\n<ul>\n <li><span>Lead investigations into deviations, complaints, and quality events to identify true root cause.&nbsp;</span></li>\n <li><span>Analyze quality trends and identify opportunities to reduce defects and improve performance.&nbsp;</span></li>\n <li><span>Implement corrective and preventive actions that are effective, timely, and sustainable.&nbsp;</span></li>\n</ul>\n<p><span><strong>Act with Urgency in Audits and Quality Events</strong></span></p>\n<ul>\n <li><span>Lead customer audits and regulatory inspections, including preparation, hosting, and response management.&nbsp;</span></li>\n <li><span>Conduct internal audits and ensure findings are addressed quickly and effectively.&nbsp;</span></li>\n <li><span>Drive timely closure of audit observations and CAPAs.&nbsp;</span></li>\n</ul>\n<p><span><strong>Build Partnerships Through Respect and Collaboration</strong></span></p>\n<ul>\n <li><span>Work closely with Production, Quality Control, Regulatory, and other functions to resolve quality issues and improve processes.&nbsp;</span></li>\n <li><span>Support vendor qualification and inspection activities.&nbsp;</span></li>\n <li><span>Communicate clearly and constructively to align teams around quality expectations.&nbsp;</span></li>\n</ul>\n<p><span><strong>Strengthen Capability and Quality Culture</strong></span></p>\n<ul>\n <li><span>Ensure employees are trained and confident in applying Curia standards, procedures, and cGMP requirements.&nbsp;</span></li>\n <li><span>Reinforce a culture where quality, safety, and accountability are part of everyday work.&nbsp;</span></li>\n</ul>\n<p><span><strong>Support Validation and Continuous Improvement</strong></span></p>\n<ul>\n <li><span>Support validation activities for methods, equipment, and facilities (IQ, OQ, PQ).&nbsp;</span></li>\n <li><span>Recommend improvements to systems, equipment, and processes to enhance quality and reliability.&nbsp;</span></li>\n</ul>\n<p><span><strong>Safety and Additional Responsibilities</strong></span></p>\n<ul>\n <li><span>Promote safe work practices and ensure safety remains a priority in all activities.&nbsp;</span></li>\n <li><span>Support additional quality and site initiatives as needed.</span></li>\n</ul>\n<p><span><strong>QUALIFICATIONS</strong></span></p>\n<p><span><i>To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.</i></span></p>\n<p><span><strong>Education and/or Experience</strong></span></p>\n<p><span>Bachelor of Science in Chemistry or a related field plus five years’ experience in pharmaceuticals or a related industry</span></p>\n<p><span><strong>Language/Communication Skills&nbsp;</strong></span></p>\n<p><span>Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.&nbsp; Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.&nbsp; Ability to write speeches and articles for publication that conform to prescribed style and format.&nbsp; Ability to effectively present information to top management, public groups, and/or boards of directors.</span></p>\n<p><span><strong>Mathematical Skills&nbsp;</strong></span></p>\n<p><span>Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.&nbsp; Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.</span></p>\n<p><span><strong>Reasoning Ability&nbsp;</strong></span></p>\n<p><span>Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.</span></p>\n<p><span><strong>PHYSICAL DEMANDS&nbsp;</strong></span></p>\n<p><span>The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.</span></p>\n<p><span>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.&nbsp; The employee is occasionally required to stand, walk, and reach with hands and arms.&nbsp;The employee must frequently lift and/or move up to 10 pounds.&nbsp; Specific vision abilities required by this job include close vision, and ability to adjust focus.</span></p>\n<p><span><strong>WORK ENVIRONMENT&nbsp;</strong></span></p>\n<p><span>The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.</span></p>\n<p><span>While performing the duties of this job, the employee is occasionally exposed to toxic or caustic chemicals.&nbsp;The noise level in the work environment is usually quiet.</span></p>\n<p><span><strong>Good Manufacturing Practices &amp; Good Documentation Practices</strong></span></p>\n<ul>\n <li><span>Expert level of understanding of US FDA regulations and cGMP.&nbsp; Ensure staff are knowledgeable in US FDA regulations &amp; cGMP requirements to perform their job function.</span></li>\n <li><span>Ensure site personnel perform all documentation in compliance with ALCOA and</span><span>&nbsp;</span><span>good documentation practices as defined by site SOP’s.&nbsp;</span></li>\n <li><span>Oversee and monitor performance of staff to ensure compliance with all cGMP SOP’s.</span></li>\n <li><span>Review cGMP related documentation to ensure Good Documentation Practices have been adhered to.&nbsp;</span></li>\n <li><span>Strict compliance with all cGMP documents</span>\n  <ul>\n   <li><span>SOP’s, Batch records, protocols, change controls, controlled forms, etc.</span></li>\n  </ul></li>\n <li><span>Ensure all cGMP applicable training is kept current for yourself and subordinates</span></li>\n <li><span>Provide training and guidance to staff and site personnel as needed on site SOP’s, Batch records, protocols, change controls, controlled forms, etc.&nbsp;&nbsp;</span></li>\n <li><span>Ensure staff have appropriate training documented prior to assigning work.</span></li>\n <li><span>Escalate any quality concerns and proposed compliant solutions to the&nbsp;</span></li>\n <li><span>Quality department.&nbsp;</span></li>\n <li><span>Perform job functions in compliance with applicable US FDA regulations and current Good Manufacturing Practices.&nbsp;</span></li>\n</ul>\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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