CGMP Data Specialist

Randstad Enterprises is looking for an experienced GMP Data Specialist to join the Parenteral team of a Pharma manufacturing company in Durham, NC. This position comes with opportunity, training, career counseling, and benefit options.

Job Details:

100% onsite in RTP/Durham

M-F 8am to 5pm

1 year contract

The day to day of this position will be coordinating with QA and MFG teams to ensure that the data generated through manufacturing activities is maintained, reviewed, corrected, analyzed and/or assessed, ensuring accuracy and compliance.

Experiences working with:
• PRIMER/batch related data entry
• Attention to detail related to Batch Records and Documentation Review
• Documentation Management

Job Focus:

Documentation and Data Management (80-90%):
• Data mining
• metric development
• Batch records
• Documentation reviews
• Compilation
• Quality
• Reconcile manufacturing materials as part of batch record review process.

Who You Are:
• Independent Worker
• Strong attention to detail and time management
• Effectively manage time
• Clear communicator

Skills needed for Success:
• Detailed with excellent documentation skills (batch records, SLRs, and logbooks)
• Ability to perform and learn to lead operations and/or support the team
• Motivated to perform most functions with minimal supervision when necessary
• Experience monitoring processes against batch records & control systems

Education:
• 2 year or bachelor’s degrees
• Minimum: HS degree and 6+ months experience
• A Plus: Biowork certification and cGMP practices