Compliance Specialist I

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The Opportunity
Description
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 government regulation.
• Conducts internal audits of manufacturing processes to ensure compliance.
• Conducts review of testing results.
• 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
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

Skills:

• 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?