Investigation Specialist II
Job Description
Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
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 II will join the ACMF Investigations team, conducting GMP investigations including manufacturing deviations, product quality excursions, and GMP facility issues. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Author manufacturing investigations within ACMF quality system. The Investigation Specialist II will be responsible for executing investigations with moderate complexity, scope, and impact.
Facilitate cross-functional root cause analysis and corrective action/preventive action (CAPA) planning
Lead routine meetings with record stakeholders (ACMF Operations, Quality Assurance, project teams) to discuss status of open investigations
Manage investigation timelines against product dispositions
Learn, access, and navigate enterprise systems as necessary for information collection (sample management, inventory systems, etc.)
Support audits as needed
Qualifications
Must-Have
BS/BA in Chemical Engineering, Biotechnology, Microbiology, Cell Biology, Biochemistry or equivalent with 2+ years of experience in relevant position (GMP biologics manufacturing, Quality Assurance, scientific roles, etc.) OR Master's Degree with 0+ years of experience
Advanced technical writing skills
Proficient in Microsoft Word
Ability to self-manage timelines and deliverables
Advanced interview skills
Strong organizational skills with demonstrated attention to detail
Nice-to-Have
Basic 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:
Last Date to Apply for Job: April 1st, 2024
Work Location Assignment: Flexible
Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so.
The annual base salary for this position ranges from $64,600.00 to $107,600.00. 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.
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.
