28 days old

Quality Batch Record Reviewer

Kelly Services
Norristown, PA 19404
Quality Batch Record Reviewer

The Quality Batch Record Reviewer is primarily responsible for batch record review and ensuring that operations are conducted in accordance with current Good Manufacturing Practice.

Responsibilities include but are not limited to: Review and approve Executed batch records. Support Product release, including review of validation reports and other supporting documentation to ensure that all information contained within, is correct and accurate Review and approve Master Batch Records and related Minor Document Change Requests. This will involve interaction with internal and external customers to achieve required timelines while maintaining product quality and compliance Actively support investigation of Batch related deviations and complaints. Ensure all internal and customer timelines are met. Liaison with clients to ensure quality expectations are met, including attending client meetings Assist in the compilation and review of APRs, and Risk Assessments Support and feed into the batch record KPIs and quality system metrics to identify trends and facilitate management review. Provide regular updates to the QA Team Leader regarding work allocation and notify of any issues which may impact the client quality issues, batch record completion deadlines, etc. Notify the QA team lead of any issues which are, or may become, a GMP compliance issue. Support internal and external audits to ensure GMP compliance and assist in customer and regulator audits, as appropriate Additional duties related to the assurance of GMP compliance and quality of packaged and released pharmaceutical products, may also be assigned.

Qualifications: Required Experience / Education: HS Diploma 2 years relevant experience in a pharmaceutical quality assurance position Packaging or Manufacturing experience Knowledge of the basic GMP requirements of the pharmaceutical industry GMP document auditing/review

Preferred Experience / Education: Bachelors Degree Experience with the generation, execution and review of quality documents in a commercial pharmaceutical packaging facility, specifically batch record review Knowledge of the regulatory requirements and industry standards for pharmaceutical packaging processes.

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2020-08-28 Expires: 2020-09-28

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Quality Batch Record Reviewer

Kelly Services
Norristown, PA 19404

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