Quality Assurance - QA​/QC

We are seeking a detail‑oriented Lab Technician to join our pharmaceutical manufacturing team on a contract basis. This role is critical to maintaining quality standards and ensuring regulatory compliance in a fast‑paced cGMP environment. The ideal candidate will perform quality control testing, support manufacturing operations, and maintain laboratory systems while adhering to strict pharmaceutical industry standards.

• Execute QC tasks essential to pharmaceutical manufacturing operations
• Perform inspections, sampling, and in‑process testing of packaging, labeling, and raw materials
• Conduct analytical testing following validated methods and company Standard Operating Procedures (SOPs)
• Prepare supplies and materials for laboratory testing activities
• Troubleshoot and resolve laboratory instrument issues to minimize downtime

• Maintain strict compliance with current Good Manufacturing Practices (cGMP)
• Document all laboratory activities in accordance with FDA 21 CFR Part 11 electronic records requirements
• Review and verify labeling accuracy against regulatory guidelines and specifications
• Support regulatory inspections, audits, and cleaning validation activities
• Identify and promptly elevate quality, safety, or compliance concerns to management

• Maintain and update Laboratory Information Management Systems (LIMS) with accurate data entry
• Manage inspection files, retention policies, and packaging component records
• Oversee reserve sample inventory, including proper retention schedules and disposal procedures
• Prepare reports and progress updates on laboratory activities for management review

• Adhere to all safety protocols, including MSDS requirements and facility hygiene plans
• Collaborate with QA management on quality improvement initiatives and inspection readiness
• Participate in cross‑functional teams to support operational excellence

Required Qualifications

• Completion of 20+ credit hours in a science‑related field (Chemistry, Biology, Biochemistry, or related discipline)
• Minimum one year of hands‑on laboratory experience within a cGMP‑regulated pharmaceutical or biotech facility
• Working knowledge of cGMP requirements and quality control principles
• Proficiency with LIMS systems and electronic documentation practices
• Strong attention to detail with excellent organizational and time management skills
• Ability to follow written procedures precisely and maintain accurate records
• Effective communication skills for interacting with cross‑functional teams

• Bachelor's degree in Chemistry or related scientific discipline
• Advanced understanding of laboratory instrumentation theories and applications, including:
  • Spectrophotometry
  • High‑Performance Liquid Chromatography (HPLC)
  • Other analytical techniques used in pharmaceutical testing
• Previous experience supporting regulatory audits or FDA inspections
• Familiarity with cleaning validation processes and protocols

This contract position is based in a cGMP pharmaceutical manufacturing facility requiring adherence to cleanroom protocols, personal protective equipment (PPE), and strict safety standards. The role involves standing for extended periods, working with laboratory equipment, and handling chemical materials according to established safety procedures.

• After 30 days of employment, you will qualify for health benefits, including medical, dental, and vision coverage.
• You will accrue 1 hour of PTO for every 35 hours you work; it starts accruing immediately.
• Paid overtime.