QA Chemist

Responsibilities

• Review analytical raw data, chromatographic sequences, laboratory notebooks, and calculations for scientific accuracy and cGMP compliance.
• Evaluate analytical documentation supporting method development, validation, release testing, stability studies, and investigations.
• Verify adherence to approved specifications, SOPs, protocols, and data integrity expectations (ALCOA+).
• Identify discrepancies or atypical results and provide clear, actionable feedback to QC analysts and supervisory staff.
• Approve analytical protocols, validation reports, stability summaries, and related controlled documents within QA review authority.
• Collaborate with QC, QA, and cross-functional partners to resolve data issues, support root-cause analyses, and ensure timely documentation.
• Support audit and inspection readiness by preparing data packages and ensuring records are accurate, complete, and easily retrievable.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field; Master’s degree preferred.
• Minimum 2 years of experience in a GMP-regulated pharmaceutical environment, ideally within QA or QC.
• Hands-on experience performing or reviewing analytical data, including HPLC/GC/UV methods and laboratory documentation.
• Strong working knowledge of cGMP, ICH guidelines, FDA requirements, and data integrity principles (ALCOA+).
• Excellent attention to detail, documentation accuracy, and communication skills, with proficiency in Microsoft Office and familiarity with chromatography data systems (e.g., Empower, Chromeleon).

Qualifications

We are looking for applicants with:

• Experience in a GMP-regulated pharmaceutical environment, ideally within QA or QC.
• Hands-on experience performing or reviewing analytical data, including HPLC/GC/UV methods and laboratory documentation.
• A strong understanding of cGMP, ICH guidelines, FDA requirements, and data integrity principles (ALCOA+).
• Proficiency in Microsoft Office and familiarity with chromatography data systems (e.g., Empower, Chromeleon).

Skills

• Strong analytical expertise.
• Experience with laboratory data review.
• Ability to partner with QC staff to support compliant documentation, timely investigations, and inspection readiness.

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Anual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays