Associate - Quality Systems Chemical Research & Development Manufacturing
The Chemical Research and Development (CRD) Manufacturing Team in Groton, CT is seeking candidates for a Quality Systems Associate. This role is part of Worldwide R&D and has responsibility for the execution and documentation of Quality System program elements in support of regulated drug substance manufacturing operations. This role will report to, and take primary direction from, the Groton CRD Manufacturing Quality Systems Lead.
The Quality Systems Associate will coordinate and collaborate with personnel from CRD Manufacturing, Quality Assurance, and other stakeholder groups to progress key quality and compliance-related documentation deliverables. These include Investigations, Corrective and Preventative Actions (CAPA), System Lifecyle documents (Qualification, Periodic Review), Training System elements, and Standard Operating Procedures. In some instances, the Quality Systems Associate may directly interface with support lines and access the Pfizer software platforms used to execute these tasks (Trackwise, GDMS, etc.)
- Maintain current knowledge of regulatory requirements and the Pfizer compliance environment to be able to perform activities defined by CRD Manufacturing Quality Systems and provide compliance guidance to key stakeholders.
- Actively participate/co-lead in the CRD Local Compliance Forum – a recurring cross-functional meeting that is a prominent element of the Pharm Sci Quality Governance model. May act as representative on cross business line Quality Councils (site and global).
- Develop and maintain robust working relationship with Engineering and Quality support groups.
- Extract and report metrics/ key performance indicators to measure quality compliance.
- Assists CRD Manufacturing with management of completed batch documentation, including post-execution reviews and archiving workflows.
- Contribute to the timely completion of quality incident investigations, including root cause determination and effective Corrective and Preventative Action determination.
- Author Standard Operation Procedures.
- Participate in equipment and computer system validation lifecycle activities to include, commissioning, qualification, periodic review, retirement, and change control management.
- Minimum B.S. in Chemistry, Biology, Engineering or other relevant scientific discipline with 0-2 years’ experience.
- Familiarity with current Good Manufacturing Practices.
- Demonstrated ability to organize and execute own work to further Team objectives.
- Candidate must possess effective oral and written communication skills.
- Able to function proficiently in a digital work environment.
- Demonstrated competency with Microsoft Office suite of products.
- Awareness of Continuous Improvement/ Lean Manufacturing methodologies (Six Sigma, 5S).
- Awareness of the pharmaceutical development continuum.
- Prior experience in a manufacturing/manufacturing support role.
- Prior experience working with enterprise software platforms for investigations/asset management.
Candidate must be physically capable of sitting or standing for prolonged periods, be amenable to wearing personal protective equipment, and working in proximity to manufacturing equipment and hazardous materials.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Manufacturing#LI-PFE