Description:

• Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and approval of incoming materials for release. The position will provide floor support to production departments to include line clearances, in-process checks and assistance with investigations.

• Review and approve supplemental logs, charts and other documents in support of cGMP Operations.

• Review batch records for accuracy and completion prior to final release of product.

• Perform product releases specifically fills and intermediates lots.

• Coordinate product releases with distributors and customers as needed.

• Review and approve incoming materials for release.

• Provide quality assurance support of investigations including: nonconformance and root cause analysis.

• Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned.

• Issue, review and reconcile batch records as needed.

Skills:

Quality assurance, Compliance, GMP, Document control, Batch Record, Batch Record Review, product release, investigations, Root cause analysis, iso 13485, audit, quality compliance

Additional Skills & Qualifications:

• Bachelor’s Degree or relevant experience in the life sciences.

• 1-2 years minimum experience in the medical device and/or pharmaceutical industries working in a Quality Assurance/Quality Compliance role.

• Knowledge of GMP, FDA, ISO requirements.

• Requires computer competence, including experience with databases and Microsoft Office.

• Excellent written and verbal communication skills.

• Desired Experience, Knowledge, and Skills:

• Experience working in a GMP/ISO environment.

Experience Level:

Entry Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.