Teva BS Microbiology Quality Compliance Job – Apply Online
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.
Job Title: Microbiologist Quality Compliance III
Location: West Chester, United States, Pennsylvania, 19380
Your experience and qualifications
- BS/BA or Undergraduate degree in microbiology.
- Minimum 5 years of experience in an aseptic processing environment.
- Expert knowledge in quality compliance (cGMP, ICH, FDA, EMA, USP/EP policies & guidelines) required.
The opportunity
The Microbiologist Quality Compliance III role is filled by a professional who possesses the compliance and Regulatory knowledge and skills in Environmental Monitoring, sampling plans, aseptic processing technique necessary to provide direction and guidance in current Good Manufacturing Practice (cGMP) regulations for commercial and clinical biopharmaceutical manufacturing in an on-the-floor setting. The incumbent works to assure the quality, accuracy, and integrity of data in manufacturing operations, in-process and release testing. The incumbent applies experience and excellent communication skills within a collaborative environment to assure that the GMP Quality culture are embraced by the site to enable a commitment to continuous quality improvement and embrace a permanent inspection ready attitude.
The position involves expert knowledge of Annex 1, FDA Guidance for Industry, USP/EP/JP Chapters, and their requirements at the site.
Essential Responsibilities
- Provide QA support for GMP activities in the BMF with regards to all aspects of the on-going microbiological and environmental monitoring program for facilities, utilities equipment and GMP activities on the shop floor.
- Provide support, oversight review and approval (as required ) for:
- QA oversight on shop floor and routine walk thru inspections
- Review and oversight of EM sampling of BMF operations
- Review and oversight of water sampling
- Evaluation of BAS alarms and set points and trending
- Review and QA oversight of air flow patterns, personnel flow, differential pressure
- Ensure activities are performed/completed using current Good Manufacturing Practices.
- Serve as Quality resource, representing QA on teams in support of assignments.
Provide feed-back/communication of any issues. - Review and approve SOPs, work instructions, and controlled forms.
- Utilize Quality Systems to review and approve change controls, deviations, investigations, CAPAs and CAPA Effectiveness checks.
- Participate/support regulatory agency filings, inspections, and internal audits, as needed.
- Possess strong understanding of gowning and aseptic techniques for controlled/classified environments.
- Assess manufacturing activities for proper aseptic techniques.
- Review of production records and EM reports ensuring quality and proper cGMP documentation.
- Author and/or support authoring of technical documents.
- Author and/or support gap assessments of local SOPs to corporate standards.
- Update local SOPs, forms and work instructions as applicable.
- Support general QMS activities and initiatives.
- Support GMP compliance and inspection readiness initiatives.
- Support regulatory agency filings and inspections.
- Ensure activities are performed/completed using current Good Manufacturing Practices
- Utilize Quality Systems to review and approve change controls, deviations, laboratory investigations, CAPAs and CAPA Effectiveness checks.
Additional Compliance Responsibilities
- Use of Microsoft Word, Excel, and PowerPoint to support compliance team activities.
- Serve as Quality resource, representing QA on teams in support of assignments.
Support cross functional department customers in a manner which is clear in approach, communication and action. - Assist in the preparation and presentation of site Quality Council.
- Assist in the execution of Internal Audits.
Teva BS Microbiology
