Quality Assurance Supervisor

Pine Pharmaceuticals•Tonawanda, NY

1d•$65,000 - $75,000

About The Position

Oversees the daily activities of QA Batch Release and Document Control personnel to ensure timely and compliant execution of cGMP requirements, including quality review of batch production records, issuance of production batch documentation, and batch disposition and release. Ensures the accuracy, completeness, and integrity of raw data, batch records, and associated test results prior to product release. Responsible for the oversight and performance management of QA Batch Release and Document Control staff within a cGMP 503B outsourcing facility. Reviews and/or approves required documentation to ensure compliance with applicable regulations, internal policies, and procedures. Collaborates cross-functionally with manufacturing, quality control, and other departments to resolve batch record documentation issues efficiently and support timely release of finished goods.

Requirements

Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, Microbiology, or related life science) with 7+ years of experience in a GMP-regulated pharmaceutical, biopharmaceutical, or medical device environment; or Associate’s degree in a related scientific discipline with 10+ years of relevant pharmaceutical GMP experience, including progressive QA responsibilities.
In lieu of a degree, candidates with a High School diploma (or equivalent) may be considered with 15+ years of progressive Quality Assurance experience in a pharmaceutical or biopharmaceutical GMP environment, including demonstrated leadership responsibility and technical oversight of batch release or quality systems.
Minimum of 3 years of experience performing QA batch record review, batch release, or quality systems oversight within a pharmaceutical GMP environment.
Proven leadership experience, including managing, mentoring, and developing QA staff, establishing priorities, and driving compliance with cGMP standards.
Strong technical knowledge of pharmaceutical manufacturing processes, cGMP requirements, quality documentation, and regulatory compliance, with the ability to analyze complex quality data and make independent decisions regarding batch disposition and quality risks.
Strong knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and data integrity principles in a regulated pharmaceutical environment.
Knowledge and understanding of CFR Parts 210 and 211 and 503B compounding guidelines.
Working knowledge of quality systems, including but not limited to deviations, NONC, and CAPA.
Accurate/legible completion of records and documents for tests performed, and accurate computer data entry. Strong technology skills (Windows, Word, Excel, Power Point).
Experience utilizing ERP and/or electronic quality management systems (e.g., MasterControl) for batch disposition, document management, and workflow tracking.
Demonstrated ability to lead, mentor, and develop team members, fostering accountability, collaboration, and continuous improvement within a regulated quality environment.
Strong organizational, problem-solving, and decision-making skills with the ability to manage multiple priorities and meet production and distribution timelines.
Effective communication and cross-functional collaboration skills to work with Production, Quality Control, Regulatory Affairs, and other departments to resolve documentation and compliance issues.
Good time management skills, attention to detail, ability to adhere to implemented standard operating procedures/policies, and flexibility for new opportunities/tasks.
Works well independently while maintaining a team-oriented mindset.
Possess a professional appearance, with excellent interpersonal communication skills including presentation skills, and multitask ability.

Nice To Haves

Experience supporting QA/QC operations in a 503B outsourcing facility a plus.

Responsibilities

Supervise daily activities of the QA Batch Release and Document Control teams to ensure efficient workflow and compliance with cGMP requirements.
Assign and prioritize daily tasks for document control to support timely batch record review and product release.
Review and oversee documentation for accuracy and completeness, including production batch records, media fills, stability studies, and I&D batches.
Review and approve quality documentation, including deviations, change requests, and other batch-associated records, ensuring compliance with cGMP and internal procedures.
Ensure proper batch disposition and release through ERP systems, including notification of product availability and routing of approved product for distribution.
Verify that batch-associated deviations, nonconformances, and quality events are appropriately reviewed prior to batch release.
Identify documentation discrepancies and coordinate revision to resolve errors or omissions.
Manage document workflow to support first-in-first-out batch release while aligning with site needs.
Oversee lifecycle management of Master Production Records and Batch Production Records, including issuance, reconciliation, revision, and archival in accordance with data integrity and GDP.
Manage site logbooks in compliance with cGMP standards, including issuance, reconciliation, review, archival, and document revisions.
Collaborate cross-functionally with Production, QC, and Regulatory Affairs to ensure compliance with applicable regulations and internal procedures (e.g., FDA, USP, State Boards of Pharmacy).
Promote continuous improvement initiatives to strengthen document control processes, data integrity, and overall quality system performance.
Train, mentor, and evaluate team members, provide performance feedback, and assist in resolving team issues.
Prepare and present key quality metrics to management.
Develop and maintain team schedules and delegate responsibilities to meet organizational priorities.
Perform other duties as assigned to support departmental and company objectives.