QA Specialist I

Employer
Pfizer
Location
Andover, Massachusetts
Posted
Jul 30, 2021
Ref
4820663
Required Education
High School or equivalent
Position Type
Full time

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 clinical and 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. You will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will provide input to investigations and change control activities to ensure compliance with configuration management policies.

As a QA Specialist I, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for 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 I Demonstrates sufficient depth of knowledge within own work area in order to perform hands-on routine QA tasks. This role supports Operations including batch record, investigation, and document review, and disposition activities. Resolve routine quality issues related to product manufacture and testing with guidance/coaching. Project work, as needed, will also be expected.

  • Provides ongoing site-based Ops support for both start up and ongoing product manufacturing.

  • Competently reviews simple batch records and associated simple deviations and simple analytical investigations. (Cal OOTs, RAAC, CIS and Events)

  • Able to resolve less challenging quality issues and make simple batch disposition decisions with guidance and coaching.

  • Able to review and approve documents in PDOCS with quality mindset.

  • Uses established QA procedures and methodologies to propose solutions for straight forward problems with guidance and coaching

  • Makes decisions that require knowledge of quality systems.

  • Represents QA on various Teams with direction from management.

  • 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 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.

  • Present as QA-on-the-floor on a fixed schedule each week.

Qualifications

Must-Have

  • Bachelor's Degree in Biology, Chemistry, Engineering, or related Technical Physical Science with 0-2 years of experience in GMP Pharmaceutical Manufacturing Environment required OR High School Diploma or Equivalent with 4+ years of experience in GMP Pharmaceutical Manufacturing Environment required.

Nice-to-Have

  • Experience in writing and managing deviations.

  • Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management.

Physical/Mental Requirements

  • Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.

Non-Standard Work Schedule, Travel, or Environment Requirements

  • Position is first shift Monday through Friday (8 Hours per day) or four ten-hour shifts. Some occasional off hour (night/weekend/holiday) support may be required to support staff and operations.

 Other Details:

  • Last Date to Apply: August 12, 2021

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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