POSITION SUMMARY:

The QA Specialist is responsible for independently conducting thorough review of batch production records and supporting documentation to ensure products meet FDA, EMA, and internal QMS requirements prior to disposition and release. Applies working knowledge of cGMP regulations, SOPs, and quality systems to identify discrepancies, support deviation management, and contribute to continuous improvement initiatives within a CDMO environment.

PRINCIPAL DUTIES:

Batch Record Review

Independently review executed batch records and associated documents (testing reports, equipment logs, deviations, cleaning records) for completeness, accuracy, clarity, and compliance with SOPs and regulatory requirements.
Review draft batch records for completeness, accuracy, and clarity prior to manufacturing.
Verify critical process parameters, in-process controls, and documentation entries against approved master batch records and specifications.
Identify and document discrepancies or missing information; escalate appropriately to senior specialist or supervisor.
Review deviations impacting batch quality and ensure proper documentation and closure prior to batch release.
Verify final completeness of batch record information prior to releasing the batch record.
Perform creation and scanning of batch record package binders (Manufacturing Batch Records and Labeling and Packaging Batch Records).
Follow cGMP/cGDP, FDA compliance, and ALCOA+ data integrity principles consistently.

Deviation & CAPA Support

Review and support the documentation and closure of deviations impacting batch quality.
Assist in CAPA development and implementation related to recurring batch record errors.
Report nonconformances and follow escalation pathways per SOPs.
Identify trends and recurring errors; communicate findings to supervisor.

Documentation & Compliance

Maintain and control quality records in accordance with document control procedures.
Support documentation review activities (e.g., batch record documentation, environmental monitoring records).
Adhere to regulatory standards (FDA, EMA, ICH, ISO, GMP) in all review activities.
Participate in internal audits and support external inspections as needed.

Continuous Improvement

Identify inefficiencies in batch record review workflows and communicate observations to QA leadership.
Recommend process improvements to enhance speed, accuracy, and compliance.
Assist in the revision of SOPs and work instructions related to batch record review.
May perform other duties as assigned.

JOB REQUIREMENTS:

Working knowledge of cGMP (US, EU, ICH) regulations and manufacturing processes (Formulation, Filling, Packaging).
Demonstrated proficiency in batch record review and product release activities.
Ability to identify compliance gaps and document findings clearly and concisely.
Familiarity with quality systems including Deviation, CAPA, Change Control, and Document Control.
Strong attention to detail and documentation skills consistent with ALCOA+ principles.
Good verbal, written, and organizational communication skills.
Ability to work independently with minimal supervision while adhering to timelines.
Team player with a continuous-improvement mindset.
Must demonstrate integrity, accountability, sound judgment, and a commitment to quality.
Proficient in electronic quality management systems (eQMS) and Microsoft Office.

EDUCATION and/or EXPERIENCE:

Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Engineering, or related field preferred; or Associate's degree (AS) with relevant experience.
2–4 years of experience in batch record review and/or product release in a GMP-regulated environment.
Experience in QA within a regulated industry (pharma, biotech, medical devices, CDMO).
Demonstrated understanding of FDA and/or EMA regulatory requirements for batch record review and product release.

Physical Requirements

Ability to lift and carry boxes or binders weighing up to 25 lbs.
Ability to stand, walk, and move between departments or storage areas as part of regular duties.

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