Senior Quality Specialist: Lab Compliance Chemistry

Location: Lancaster, Pennsylvania, USA; candidates must live within a commutable distance. Full-time, Monday–Friday, 8:00 a.m.–5:00 p.m., with additional hours as needed.

Company

hirify.global Scientific provides analytical testing and laboratory services across food, environmental, pharmaceutical, cosmetic, genomic, clinical, and agroscience fields.

What you will do

• Monitor laboratory compliance with GMP/GLP and cGXP requirements, including reagent control, labeling, cleanliness, training records, PPE, and other audit-readiness items.
• Perform and support internal audits and help implement resolutions for internal and external audit findings.
• Review instrument qualifications, invalid data, system suitability failures, deviations, exceptions, and non-routine events.
• Approve analytical methods, protocols, SMIS, and client parameters according to QA procedures.
• Track quality metrics, identify recurring trends, train laboratory personnel, and support CAPA implementation and quality improvements.
• Communicate compliance findings and rework requirements to internal clients while advising analysts on QA/QC data matters.

Requirements

• Bachelor’s degree in Chemistry or a related scientific field.
• At least three years of pharmaceutical laboratory experience with knowledge of regulatory requirements.
• Authorization to work indefinitely in the United States without restriction or sponsorship is required.
• Experience with pharmaceutical analytical testing, technical writing and review, batch record review, pharmaceutical testing, and room clearance activities.
• Ability to track action items through completion, identify trends, solve problems, and exercise independent judgment.
• Computer skills with word processing, spreadsheets, presentations, and databases.

Nice to have

• Experience in cGMP and/or FDA-regulated environments.
• Experience supporting internal audits and reviewing or writing QAU procedures.

Culture & Benefits

• Comprehensive medical coverage.
• Life and disability insurance.
• 401(k) plan with company match.
• Paid holidays and vacation.
• Dental and vision options.