Investigation Specialist I
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. However we must only include sections when posting has real specific content. We need to map content to these headings. We have: - About the role: The introductory paragraph describing mission, purpose, etc. Could be "About the role". We'll include that. - Responsibilities: The "What You Will Achieve" list (lead and author GMP investigations, conduct fact-finding, facilitate teams, partner with teams, drive investigations, evaluate trends, support audits, contribute to initiatives). That's responsibilities. - Requirements: Could be "Qualifications" (must have). But we also have "Nice to Have" which could be Skills? Actually we have Qualifications (must have) and Nice to Have (additional). The headings list includes Qualifications, Skills. We could put Must Have under Qualifications, Nice to Have under Skills. Or combine. - Physical/Mental Requirements: Could be under Requirements? But we have a separate heading "Requirements". Could use that for physical/mental? However we also have Qualifications. The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have multiple sections: About the role, Responsibilities, Qualifications, Skills, Benefits, Pay, maybe Requirements (physical/mental). We need to decide. We have content: Physical/Mental Requirements: Ability to perform mathematical calculations and complex data analysis; Ability to gown into/out of manufacturing clean rooms. That's specific. So we can make a section "Requirements" with that. We have Work Location Assignment: On Premise. That's maybe not a heading; could be included in a short paragraph under About the role or maybe under Responsibilities? But we can include as a short
maybe under About the role? The instruction: do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Work location is minor metadata; we can put in a short
. We have salary and benefits: Pay and Benefits sections. We have salary range and bonus target. Also benefits description. So we can have Pay section with salary and bonus. Benefits section with benefits list. Schedule: Not mentioned. So we should not include Schedule heading. We must not include boilerplate like EEO, legal, etc. Remove those. We must preserve all substantive information; do not invent or summarize away detail. So we need to keep all details from the posting that are substantive: the mission paragraph, the responsibilities list (each bullet), qualifications must have list, nice to have list, physical/mental requirements, work location, salary, bonus, benefits list, relocation assistance note, work authorization, sunshine act note? The sunshine act is legal/boilerplate? It's about reporting payments to health care providers; might be considered legal boilerplate. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. Sunshine Act is legal; likely remove. Also EEO & Employment Eligibility is boilerplate; remove. Also accessibility statement; remove. Also candidate AI-use guidelines; remove. Also "Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com)" maybe part of benefits; we can keep benefits description but maybe drop the link? The instruction: preserve ALL substantive information; do not invent or summarize away detail. The link is part of benefits info; maybe we keep as part of benefits paragraph but not as a heading. It's not boilerplate; it's a reference. Could keep. Also "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." That's substantive about salary location; keep. "Relocation assistance may be available based on business needs and/or eligibility." Keep. "Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future." Keep. Now we need to format. We'll produce:
About the role
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. Your contributions will be vital in achieving project tasks and goals, fostering a collaborative team environment, and enabling Pfizer to reach new milestones and provide aid to patients worldwide.
Work Location Assignment: On Premise
Responsibilities
- Lead and author GMP investigations within Pfizer quality systems for manufacturing deviations, product quality excursions, equipment and facility events, and compliance-related observations.
- Conduct thorough fact-finding, data collection, and technical assessments utilizing manufacturing records, process data, laboratory data, audit trails, equipment histories, and enterprise systems.
- Facilitate cross-functional investigation teams to identify root causes using structured problem-solving methodologies and quality risk management principles.
- Partner with Manufacturing, Quality Assurance, Process Development, Engineering, Validation, and Analytical teams to determine event impact, product disposition requirements, and corrective/preventive actions.
- Drive investigations to completion while ensuring quality, regulatory compliance, and adherence to established timelines.
- Evaluate investigation trends and support continuous improvement initiatives aimed at reducing repeat events and improving manufacturing robustness.
- Support internal and external audits, regulatory inspections, and quality system assessments as required.
- Contribute to additional quality and compliance initiatives, including audit responses, CAPA effectiveness evaluations, risk assessments, and procedure development.
Qualifications
- Bachelor's degree with 0 to 2 years of relevant experience, or an Associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
- Strong technical writing and documentation skills with demonstrated ability to author complex GMP records
- Experience in a GMP biotechnology manufacturing or laboratory environment
- Ability to analyze technical data, identify trends, and present clear, evidence-based conclusions
- Excellent organizational and project management skills with the ability to independently manage multiple priorities and deadlines
Skills
- Commitment to continuous improvement and operational excellence
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity
- Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
- Experience authoring and leading cGMP manufacturing investigations, deviations, CAPAs, and quality event records
- Working knowledge of biologics manufacturing processes including cell culture, purification, filtration, formulation, and supporting utilities
- Familiarity with quality risk management and root cause analysis tools such as Fishbone, 5-Why, FMEA, Fault Tree Analysis, or similar methodologies
- Experience utilizing manufacturing and quality systems including DeltaV, SAP, Microsoft Dynamics, LIMS, electronic batch records, document management systems, and data historian platforms
- Experience supporting regulatory inspections, internal audits, and inspection readiness activities
Requirements
- Ability to perform mathematical calculations and complex data analysis
- Ability to gown into/out of manufacturing clean rooms
Pay
The annual base salary for this position ranges from $60,200.00 to $100,400.00. 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. 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.
Benefits
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).
We must not include any extra text like explanations. Only HTML fragment. Check for any leftover boilerplate: We removed EEO, legal, sunshine act, accessibility, AI guidelines, etc. Also removed "Pfizer is an E-Verify employer." etc. Also removed "This position requires permanent work authorization in the United States." Actually that is substantive about work authorization; we might need to keep it. The instruction: preserve ALL substantive information. Work authorization is substantive. Should we keep? It's not boilerplate; it's a requirement. We could include it under Requirements or maybe a short paragraph. Let's add a line under Requirements: "Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future." That's substantive. We could add to Requirements list. Also "Pfizer endeavors to make www.pfizer.com/careers accessible to all users..." is boilerplate; remove. Also "If you would like to contact us regarding the accessibility..." remove. Also "To learn more about acceptable and prohibited uses of AI during the recruitment process..." remove. Also "Manufacturing" at end? Probably part of boilerplate; remove. Now incorporate work authorization into Requirements. Update Requirements list:- Ability to perform mathematical calculations and complex data analysis
- Ability to gown into/out of manufacturing clean rooms
- Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.