We're looking for a Compliance Specialist, working in the Pharmaceuticals & Medical Products industry in Framingham, Massachusetts, United States.
Performs all aspects of lot issuance, lot review/release process, ensuring compliance to the relevant site release SOP and corporate standard.
Participates in investigation of all lot-associated deviations, change controls (CCR/LCR), Building Management System (BMS) investigations, action notices and environmental excursions as required.
Participates in investigation of non-lot associated deviations, change controls (CCR/LCR), Building Management System (BMS/EMS) Investigations, action notices and environmental excursions as required.
Ensures that documentation and operations meet established requirements of cGMPs, Internal SOPs and company policies.
Performs various QMS trending/reporting functions, FMEA/risk team member as appropriate.
The pay range we're offering is 25 to 27 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Bachelor degree with 3 years of experience or Associate degree with 5 years of experience in quality or cGMP operations. Bachelor degree in a scientific discipline or equivalent with 4-6 years industry experience preferred.
Strong technical background in regulated products.
Excellent communication skills both written and verbal.
Strong critical thinking ability.
Effective time management and organizational skills.
Strong attention to detail and ability to work with others in a group environment.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.