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 Job Summary

  • Job Title: QA Associate
  • Job Code: SA-PFE-PGS-4856770
  • Job Location: Andover, MA 01810
  • Job Date: 7/1/2022
  • Duration: Perm
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 Job Description

Rangam SourceAbled in partnership with our client Pfizer, one of the world’s largest pharmaceutical companies, is seeking QA Associate candidates for a full time direct hire position.

 

The candidate will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will be responsible for providing Quality Assurance support to GMP clinical manufacturing. 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 to ensure compliance.

 

Candidates with autism, neurodivergence and/or disabilities highly encouraged to apply.

 

Position Tasks

·          Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

·          Review and approve various Good Manufacturing Practices {also cGMP} records (primarily batch records) and investigations.

·          Ensure that all documents for batch release are reviewed for completeness and accuracy.

·          Make Quality decision to resolve moderately complex issues with assistance from management.

·          Seek out and assess internal and external compliance with applicable regulations.

·          Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role as needed.

·          Recognize when an issue is beyond your sphere of influence and escalate immediately.

·          Participate in Limited Duration Teams, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.

·          Assist and support the manufacturing staff in detecting and solving compliance errors in real time during manufacturing operations.

·          Help to define appropriate action plans for improvement and follow-up and communicate action closures.

·          May participate in the release of raw materials, as needed.

 

Qualifications

·          Bachelor's Degree

·          Sound knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards.

·          Ability to work in a team environment within own team and interdepartmental teams.

·          Excellent communication and interpersonal skills

·          Proactive approach and strong critical thinking skills.

·          Effective written and oral communication skills 

 

Nice-to-Have 

·          Experience in pharmaceutical industry

·          Experience at a manufacturing site

·          Experience of 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 is preferred

 

PHYSICAL/MENTAL REQUIREMENTS

·       Mental agility to handle a large quantity and broad scope of different types of quality assurance work.

·       Ability to work independently, problem solve and make recommendations for solutions.

·       Role is primarily office-sitting. Position requires walking, sitting, standing, and carrying batch records from one location to another as Andover site is a campus setting.

·       Able to lead and/or participate in in person or WebEx meetings.

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Shift is 1st, Monday - Friday, typically 8am -5pm, availability to work off shift hours, weekends and Holidays as needed.

 

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.

 

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.

 

To find out more about Rangam, SourceAbled, and this role, click the apply button. 

 

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