Manufacturing/Quality Documentation Specialist

Our multinational healthcare clieng is hiring for Manufacturing/Quality Documentation Specialist in Round Lake, IL.The candidate will 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.

Job Title: Manufacturing/Quality Documentation Specialist
Location: Round Lake, IL (onsite)

Candidates must not be allergic to Penicillin or Cephalosporin drugs

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

Qualifications:
• 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.

Essential Duties and 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.

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.