QA Specialist II
Job Description
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
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As a Pfizer colleague, your focus on the job will contribute in achieving project tasks and goals. Through your knowledge and commitment, you will create a collaborative team environment with your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
The QA Specialist II demonstrates increasing knowledge of cGMPs and quality processes and procedures as well as a knowledge of scientific principles associated with activities supported by the quality role. This role supports Operations including batch record, investigation, and document review, and disposition activities. Resolve routine quality issues related to product manufacture and testing under limited guidance/coaching. Project work, as needed, will also be expected.
- Provides ongoing site-based operations support for ongoing product manufacturing.
- Competent review of GMP documentation (for example: batch records, procedures, forms, logbooks) with increased complexity and associated simple deviations (CalOOTs and Events)
- Able to resolve less challenging quality issues and independently make simple batch disposition decisions under limited guidance/coaching.
- Able to review and approve documents in the site document system with quality mindset.
- Uses established QA procedures and methodologies to propose solutions for straight forward problems under limited guidance/coaching
- Makes decisions that require knowledge of quality systems.
- Represents QA on various Teams with direction from management.
- Reviews and approves change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations.
- Exercises judgment in resolving simple quality issues.
- Able to review executed batch documentation for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments.
- Manages own workload with minimum oversight by manager/peer.
- Represents their quality records with Board of Health inspectors, with support of management, as needed.
- Maintains inspection readiness and supports internal/external audits as needed.
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 Degree in Biology, Chemistry, Engineering, or related Technical Physical Science with 2+ years of experience in GMP Pharmaceutical Manufacturing Environment required OR High School Diploma or Equivalent with 6 years of experience in GMP Pharmaceutical Manufacturing Environment required OR Master's Degree in Biology, Chemistry, Engineering, or related Technical Physical Science with 1+ years of experience in GMP Pharmaceutical Manufacturing Environment required.
Nice-to-Have
- Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management.
- Experience in writing and managing deviations.
PHYSICAL/MENTAL REQUIREMENTS
- Must be able to be present at the Andover site routinely as required.
- Must be able to gown and enter the suite
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Position is first shift Monday through Friday. Some occasional off hour (night/weekend/holiday) support may be required to support staff and operations.
Work Location Assignment: On Premise
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.
