Pharmaceutical Quality Assurance Associate

Medical Recruitment Strategies · United States

Job Title: Quality Operations Specialist – 1st Shift

Location: Woburn, MA 01801 | Onsite
Job Type: Temp-to-Hire
Schedule: Monday–Friday, 6:00 AM–2:30 PM | 40 hours/week
Pay: $23–$25/hour during temp assignment; $26/hour upon permanent conversion
Start: ASAP

Job Summary:
Seeking a Quality Operations Specialist to support pharmaceutical repackaging operations through quality inspections, labeling, documentation, controlled substance tracking, and cGMP compliance.

Responsibilities:

• Perform incoming, in-process, and final quality inspections of pharmaceutical products.
• Create and revise pharmaceutical labels and drug information.
• Review production practices, equipment, and finished products for cGMP compliance.
• Maintain quality, training, and production documentation.
• Support deviation/incident investigations and quality audits.
• Track controlled substances, DEA Form 222 documentation, and ARCOS reporting.
• Conduct retain sample audits and support drug destruction activities.
• Report quality findings and out-of-specification results to management.
• Communicate with manufacturers and customers regarding drug information as needed.

Requirements:

• Bachelor’s degree in a science-related field.
• 3+ years of pharmaceutical industry experience.
• Quality experience in an FDA-regulated facility.
• Experience with pharmaceutical/medication repackaging.
• Strong attention to detail and documentation skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, and SharePoint.
• Ability to lift up to 30 lbs. and perform visual inspections.
• Reliable attendance and ability to work onsite starting at 6:00 AM.

Benefits Upon Permanent Conversion:
Medical, dental, vision, HSA, PTO, sick time, 401(k), life insurance, holiday pay, and advancement opportunities.