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We're looking for a Compliance Specialist I
, working in Pharmaceuticals and Medical Products
industry in 500 Soldiers Field Road, Boston, Massachusetts, 02134, United States
- Performs audits necessary to ensure
the compliance of manufacturing procedures to in-house specifications and
- Conducts internal audits of
manufacturing processes to ensure compliance.
- Conducts review of testing
- Reviews document and completes
inspection of returned goods.
- Performs record review to ensure the
compliance of manufacturing procedures to in-house specifications and
government regulations on the manufacturing floor and ensuring
on-the-floor presence of QA.
- Conducts review of manufacturing
processes to ensure compliance.
- Conducts review of testing results in
support of release of intermediates.
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
Education and Experience:
- Bachelors Degree and 3 years of experience, or
- Associates degree and 5 years of experience, or
- 5 years of experience in the BioTech / Pharmaceutical Industry or equivalent
- Minimum 1 year experience within Quality Control, Manufacturing, or equivalent role
- Strong computer, verbal and written communication skills
- Knowledgeable in CGMP, ICH, EMA and FDA rules, guidance and expectations
- Experience in on the job training and authoring SOPs
- Strong technical writing skills
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?