OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a remote Quality Management Specialist. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Manage batch record review to support product release and GPQ activities for commercial and clinical products (API, drug product, and finished packaged product, as assigned).
• Maintain trackers and identify trends during review of executed records and/or quality events.
• Collaborate with Technical Operations, client partners, affiliates, and subsidiaries to support product release for commercial distribution.
• Partner with ESPs, client affiliates, and Technical Operations to establish specifications, Bills of Materials, and Master Batch Records for clinical and commercial products.
• Work closely with ESPs to review process changes and improvements, investigations, and root cause analyses related to process deviations, corrections, corrective actions, out-of-trend results, and OOS events, as applicable.
• Use TrackWise Digital (TWD) to populate and submit Quality Events (QEs), Change Controls, and Batch Records for review, as assigned.
• Review analytical documentation, including stability reports, retention reports, OOS documentation, and other related materials as required.

EXPERIENCE

• Minimum of five years of combined pharmaceutical manufacturing, QA, and/or QC experience supporting commercial products and development projects.
• 5–7 years of QA experience performing batch review and release activities for suppliers or contract manufacturers (or equivalent), supporting commercial products and/or development projects preferred.
• Experience with biological products, particularly monoclonal antibodies.
• Strong communication, organizational, planning, analytical, problem-solving, and people management skills.
• Demonstrated proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Knowledge of GMP requirements for batch review and release of commercial products and/or drug development API or bulk drug product.
• Working knowledge of FDA 21 CFR Parts 210 and 211.
• Experience with TrackWise (preferred) or other Quality Management Systems (QMS) used for deviations, change controls, CAPA, investigations, etc.

EDUCATION

• Minimum of Bachelor’s degree in Chemistry, Biology, or another physical science required

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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].