What You Will Achieve
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.
How You Will Achieve It
Qualifications
Must Have
Nice to Have
PHYSICAL/MENTAL REQUIREMENTS
Other Job Details
The annual base salary for this position ranges from $74,900.00 to $124,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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 position requires permanent work authorization in the United States.
Manufacturing
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.
How You Will Achieve It
- Author manufacturing investigations within Pfizer quality systems. The Investigation Specialist III 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.)
Qualifications
Must Have
- BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent with 4 to 5 years of experience in relevant position (GMP biologics manufacturing, Quality Assurance, scientific roles, etc.) OR Master's Degree with 1+ years of experience
- Advanced technical writing skills
- Proficient in Microsoft Word
- Ability to self-manage timelines and deliverables.
- Advanced interview skills
Nice to Have
- 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 in Quality Management Systems (Trackwise, Veeva Vault, etc.)
- Demonstrated capability to assemble a matrix cross-functional team
PHYSICAL/MENTAL REQUIREMENTS
- Ability to work in a clean room environment (non-routine)
Other Job Details
- Work Assignment: On Premise
The annual base salary for this position ranges from $74,900.00 to $124,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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 position requires permanent work authorization in the United States.
Manufacturing