What are the responsibilities and job description for the QA Batch Review Specialist position at NLB Services?
Qualifications
Bachelor’s degree in Life Sciences, Engineering, or a related technical field.
3–5 years of experience in a cGMP pharmaceutical, biopharmaceutical, or CDMO environment.
Solid understanding of FDA, EMA, and ICH requirements for documentation, batch record content, and data integrity.
Strong technical writing ability with exceptional attention to detail.
Familiarity with manufacturing operations such as blending, compounding, aseptic filling, and lyophilization.
Experience using eQMS or document control systems (e.g., TrackWise, Veeva, MasterControl).
Excellent communication, problem-solving, and cross-functional collaboration skills.
Preferred Experience
Experience designing or revising batch records for biologics, sterile drug products, or other complex dosage forms.
Working knowledge of process validation and equipment qualification requirements as they relate to MBR content.
Prior experience interfacing with CDMO clients or supporting client-specific documentation formats and review cycles.
Work Environment
Primarily office-based, with routine interaction in controlled manufacturing areas.
Occasional gowning and cleanroom entry may be required for process verification or observation.