Specification Specialist - GMP/SOPs - Testing Lab

Specification Specialist

Department: Nutrition Quality Operations
Location: Collegeville, PA 19426
Industry: Pharmaceutical
Interview Schedule: Phone screen, then personal interview with hiring manager and technical team leaders.

• Specification Specialist for Global Nutrition Quality Operations will require to create, review, edit, and issue technical documents including Purchase Specifications/Testing Standards for the raw materials for the priority SAP project.
• Review compendial changes, supplier’s Certificate of Analysis (C of A) and any other supporting documents to create/edit specifications.
• Maintain periodic review of the documents.
• Utilize GMP experience to ensure completeness, accuracy, and compliance of the documents.
• Identify issues and comply with Standard Operating Procedures and associated job aids.
• Keep a tracking system for the review and approval of specifications.
• Update tracking system daily for documents during drafting, approval, and completion process.
• Coordinate review and approval process from the early commentary stage through the final approval stage.
• Maintain files and complete detailed project work as assigned.
• Create a workflow and lines of communication between departments and sites when documents are reviewed and approved.
• Devise the plan and execution to maximize the record keeping to help accelerate the delivery of documents to sites.
• Handle urgent and critical requests within a timely manor.
• Supports the ongoing responsibility of keeping technical documents in compliance with cGMP and corporate requirements.

Experience:
• 3 to 5 years pharmaceutical industry experience specially work experience in testing lab.
• Qualification: B.S. in Chemistry or scientific field



Company Information:
Long history of pioneering developments in pharmaceuticals and biotechnology, with leading products in the areas of women’s health care, neuroscience, musculoskeletal disorders, cardiovascular therapy, vaccines and infectious disease, hemophilia, immunology and oncology. A leader in the development of nutritionals.



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Reply directly to:
Jason R. Martin
Professional Recruiter
Apex Systems, Inc.
jmartin@apexsystemsinc.com
http://www.apexsystemsinc.com
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Category:	Biotech/Pharmaceutical
	> Laboratory      > Quality Assurance/Quality Control      > Document Control      > Analytical Chemistry      > Biochemistry      > Other Pharmaceutical
Location:	Collegeville, PA
County:	Montgomery County
ZIP Code:	19426
Pay Rate:	Open
Job Terms:	full time
Company:	APEX Systems, Inc.
Phone:	email only
Fax:	email only