QC Scientist III

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The Quality Control Analytical group is seeking a highly motivated and experienced candidate to support GMP analytical non-testing activities for the Raw Materials group at the Andover site. The position is responsible for writing investigation reports, change controls, technical documents, procedures, and test methods. The candidate will oversee method improvements, new material introduction, contract testing support, and trending. Support of programs includes oversight of compendial revisions, method verification/validation activities, training curricula, recognition program, quality agreements, raw material changes, and audit program.

The successful candidate will have a strong understanding of analytical testing of compendial raw materials following USP, EP, and/or JP compendia as well as non-compendial raw materials following laboratory SOPs in a pharmaceutical CGMP QC laboratory.

This position requires working collaboratively with QC Analytical and QC Micro, Investigations, Quality Assurance, Warehouse, Pharmaceutical Sciences, Manufacturing, EVM, STS, Supply Chain, and the Materials Program team. Participation in network teams will be required as needed.

This position is expected to participate in the culture of the raw materials team as well as actively participate in scheduling, visual management, metrics, and continuous improvement activities. The candidate will be expected to support additional QC Analytical business activities, as needed.

The successful candidate will be team oriented, have a passion for excellence, demonstrate equity and inclusivity, seek continuous improvement opportunities, and take pride in his or her contribution to the team.

How You Will Achieve It

• Writing and reviewing of technical documents associated with cGMP testing, investigations, change controls, raw material methods, and technical reports in support of new and existing raw materials, method verification/validation, and regulatory submissions.
• Represent Quality Control Analytical in cross functional and site product meetings.
• Support change controls, investigations, and new instrument validation. Review and approval of documentation associated with cGMP testing, investigations, change controls, and technical reports.
• Responsible for cGMP compliance and inspection of labs. Support internal and external audits.
• Point of contact for raw material testing. Collaborate with site functional areas and customers to support site goals and objectives and transfer timelines.
• Meet all timelines and deliverables in the support of the plan of record.
• Support lab testing and raw material sampling. Review data and documents for compliance and accuracy.
• Assist in assay troubleshooting and look for CI opportunities/method improvements.
• Participate and Lead Method 1/Method 2 in support of safety, compliance, and continuous improvement.
• Work on team projects as needed.
• Actively participate in visual management, standard work, and CI activities in the QC Analytical Raw Materials lab
• Participate in company culture based programs.

Qualifications

Must-Have

• Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an associate’s degree with 6 years of experience OR a bachelor’s with at least 3 years of experience OR Masters with more than 1 year of experience.
• Extensive scientific knowledge and practical application of analytical techniques (raw material testing, wet chemistry testing, analytical testing, compendial verification, troubleshooting, ID testing, and method validation)
• Knowledge and experience in cGMP test methods utilizing and applying compendial monographs and procedures such as USP/NF, EP, JP
• Strong knowledge and understanding of cGMP guidelines, USP/EP/JP requirements, FDA regulations, and industry standards, including as pertaining to validation and method transfer.
• Knowledge and experience in cGMP regulatory guidance and audits.
• Experience authoring or reviewing documentation such as SOPs and investigations
• Strong technical writing skills, including quality investigations
• Excellent communication skills both oral and written
• Candidate must be self-motivated and be able to adapt to rapidly changing project priorities.
• Proficient with computer systems (Microsoft Office) required
• Demonstrated leadership skills in decision making, planning and prioritization. Focused on team success to meet defined metrics and timelines.

Nice-to-Have

• Extensive knowledge and experience in cGMP USP/EP/JP, regulatory guidance and audits.
• Experience with DMAIC, lean, and continuous improvement tools desired
• Experience with electronic document management systems and laboratory information management systems such as LIMS, SAP, PDocs, and Trackwise strongly preferred.
• Experience authoring quality documents such as change controls, CAPAs, deviations.
• Knowledge and experience with GC and HPLC.
• The successful candidate will have a strong understanding of analytical testing of compendial raw materials following USP, EP, and/or JP compendia as well as non-compendial raw materials following laboratory SOPs in a pharmaceutical CGMP QC laboratory.

PHYSICAL/MENTAL REQUIREMENTS

Normal sitting, standing, and walking requirements to facilitate working in an office environment. Ability to support work in laboratory using appropriate personal protective equipment (PPE), as needed, such as during audits.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.

Work Location Assignment:On Premise

OTHER JOB DETAILS

• Last Date to Apply for Job: 1/28/2024
• Referral Bonus Eligibility: YES
• Eligible for Relocation Package: YES

The annual base salary for this position ranges from $78,000.00 to $126,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% 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 tendersglobal.net (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.

Quality Assurance and Control

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