Quality Assurance Specialist II/III (Pharma)

About the role

We are seeking a Document Control Specialist to join a global pharmaceutical manufacturing organization supporting critical Quality Assurance operations within a GMP-regulated environment. This is a contract opportunity with potential for extension based on business needs.

Key Responsibilities

• Perform detailed review of production batch records to ensure compliance with GMP requirements and internal quality standards
• Review highly detailed documentation packages ranging from several hundred to tens of thousands of pages
• Review chromatograms and supporting analytical documentation for accuracy and completeness
• Identify discrepancies, deviations, or compliance concerns and escalate findings to Quality Management
• Support quality systems activities including documentation review, archiving, scanning, and record verification
• Verify scans of batch production records (BPRs), chromatograms, and GMP documentation prior to archival
• Maintain accurate organization and archival of GMP records and supporting documentation
• Provide support during internal, customer, and regulatory audits
• Aid in continuous improvement initiatives and quality system support activities
• Collaborate cross-functionally with Manufacturing, QC, and Quality teams to ensure compliance and documentation accuracy

Qualifications

• QA Specialist II: Bachelor’s degree in a scientific discipline preferred; 3–5 years of QA experience within pharmaceutical, biotech, or biopharma manufacturing environments
• QA Specialist III: Bachelor’s degree in a scientific discipline preferred; 5–7 years of QA experience within pharmaceutical, biotech, or biopharma manufacturing environments

Additional Requirements

• Strong experience reviewing batch records within GMP-regulated manufacturing environments
• Strong understanding of GMP documentation practices and quality systems
• Experience reviewing chromatograms strongly preferred
• Exceptional attention to detail and organizational skills
• Ability to manage large volumes of documentation in a fast-paced environment
• Proficiency with Microsoft Office applications

Additional Information

• Team Size: Approximately 10 employees
• Reports To: QA Manager
• Interview Process: One onsite interview (~1 hour) with quick decision turnaround
• Start Date: ASAP
• Background check and drug screen required