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Qa Specialist I Jobs

Company

Pfizer
Address , Andover, 01810, Ma
Employment type FULL_TIME
Salary
Expires 2023-06-24
Posted at 1 year ago
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 clinical and commercial batches of drug substance/starting material. 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 to achieving project tasks and goals.
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 review, 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.
  • Manages own workload with oversight by manager/peer.
  • Represents QA on various Teams with direction from management.
  • Maintains inspection readiness and supports internal/external audits as needed.
  • Makes decisions that require knowledge of quality systems.
  • Ensure that all documents received in the batch release area reviewed for completeness and accuracy.
  • Represents their quality records with Board of Health inspectors, with support of management, as needed.
  • Assist and support the manufacturing/packaging staff in detecting and solving compliance errors in real time during manufacturing operations.
  • Review and approve Manufacturing records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.
  • Competently reviews simple batch records and associated simple deviations and simple analytical investigations. (Cal OOTs, RAAC, CIS and Events)
  • Supports QA on the floor rotation.
  • Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.
  • Manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • 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.
  • Exercises judgment in resolving simple quality issues.
  • Provides ongoing site-based Operations support for both start up and ongoing product manufacturing.
  • Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.
  • Able to review and approve documents in PDOCS with quality mindset.
  • Able to resolve less challenging quality issues and make simple batch disposition decisions with guidance and coaching.
  • Uses established QA procedures and methodologies to propose solutions for straight forward problems with guidance and coaching.
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.
  • Ability to work in a team environment within own team and interdepartmental teams
  • Effective written and oral communication skills
Nice-to-Have
  • Experience at a manufacturing site
  • 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 required to be onsite with possibility of hybrid flexibility.
  • 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.

Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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