Primary Talent Partners has a 10 month contract opening for a Documentation Specialist to join a multinational healthcare company in Round Lake, IL.

Pay: $25.00/hr - $27.00/hr

Contract: 10 months, extensions likely, conversion possible

Shift: 2nd shift, 3:00 PM - 11:30 PM

Summary:

This position reports to the Manufacturing functional areas. This position provides the Manufacturing documentation review. Review the batch record or any other GMP document to ensure the compliance with cGMP, Company Policies and local SOPs.

Responsibilities:

• Supporting manufacturing’s batch documentation review.
• Responsible for ensuring manufacturing’s batch records meet specifications and submitted to Quality per release schedule
• Assure batch documentation complies with GDP standards.
• Determine acceptability by using specifications and standard operating procedures.
• Ensure presence of all required documentation prior to the submission of batch folder to Quality.
• Maintain files such that documents are readily available and easily retrievable.
• Initiate and close GME work orders.
• Author Non-Conformance Records (NCRs) and Exceptions Investigations
• Author TCU documentation changes including revisions, periodic reviews and GAP assessments
• Use Maximo system to print department preventative maintenance work orders; assign and bring to completion, as necessary.
• Use SYSTECH to review and approve counts for batches.
• Initiate batch folders by performing necessary data entry.
• Support GME cycle counting as needed
• Other administrative duties as assigned.

Qualifications:

• Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation.

• Strong computer skills in MS Office Suite.
• Knowledge of documentation systems and familiarity with batch/systems documentation preferred.
• Strong attention to detail.
• Individual will work with minimal supervision in a dynamic environment while following written procedures. Must be organized and able to prioritize tasks.
• Ability to communicate efficiently verbally and in writing with all levels of the organization.
• Identify areas for continuous improvement.
• Individual must be willing to adjust work hours and work overtime based on business needs.
• Must be able to lift 30 pounds.
• Must not be allergic to Penicillin or Cephalosporin drugs.

#PTPStandard

Job Types: Full-time, Contract

Pay: $25.00 - $27.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

Education:

• Associate (Preferred)

Experience:

• Quality Documentation: 1 year (Preferred)
• GMP Documentation: 1 year (Preferred)
• Batch Record Review: 1 year (Preferred)

Work Location: In person

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