Investigation Specialist III
Pfizer
This job is no longer accepting applications
See open jobs at Pfizer.See open jobs similar to "Investigation Specialist III" Mass Digital Health.ROLE SUMMARY
The Andover Clinical Manufacturing Facility (ACMF) is located on the Pfizer Andover, MA campus and is responsible for the cGMP manufacture of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.
The Investigation Specialist III will join the ACMF Investigations team, conducting GMP investigations including manufacturing deviations, product quality excursions and GMP facility issues.
ROLE RESPONSIBILITIES
- Author manufacturing investigations within Pfizer quality systems. The Senior Lead Investigator will be responsible for executing investigations with high complexity, scope and impact.
- Lead routine meetings with record stakeholders (ACMF Operations, Quality Assurance, project teams) to discuss status of open investigations
- Serve as ACMF Investigations point of contact in team manager’s absence. Includes distribution of investigations across the team, conducting cross-functional team review meetings, etc.
- Assist in on-boarding, teaching / coaching of junior ACMF Investigations team members.
- Learn, access, and navigate enterprise systems as necessary for information collection (sample management, inventory systems, etc.)
- Manage investigation timelines against product dispositions
- Support audits as needed
- Support other ACMF documentation needs as needed on a non-routine basis (CAS assessments, audit responses, etc.)
BASIC QUALIFICATIONS
- BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent with 6+ years experience in relevant position (GMP biologics manufacturing, Quality Assurance, scientific roles, etc.)
- Advanced technical writing skills
- Proficient in Microsoft Word
- Ability to self-manage timelines and deliverables
- Advanced interview skills
PREFERRED QUALIFICATIONS
- Advanced understanding of bioprocessing techniques and equipment
- Experience with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS , etc.)
- Prior experience authoring cGMP manufacturing investigations
- Demonstrated capability to assemble a matrix cross-functional team
PHYSICAL/MENTAL REQUIREMENTS
None
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to work in a clean room environment (non-routine)
Work Location Assignment: Flexible
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer 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 Eligibility
Pfizer 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.
This job is no longer accepting applications
See open jobs at Pfizer.See open jobs similar to "Investigation Specialist III" Mass Digital Health.