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Quality Assurance Officer GCS&V QA

Employer
Pfizer
Location
Groton, Connecticut
Start date
Jul 30, 2021

View more

Discipline
Quality, Quality Assurance, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

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. 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 QA officer, your knowledge and skills will contribute towards the goals and objectives of the team.  Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
  • Support the review and approval of study documentation for clinical trial supplies to ensure compliance with procedural requirements and regulatory expectations.
  • Review and approval of pre-production and executed batch records to assure compliance with data integrity, regulatory standards and regulatory filing.
  • Disposition of packed and label supplies for clinical trial.
  • Partnering with Qualified Persons as needed to facilitate release of clinical supplies for UK or EU.
  • Supports for the global packaging operations in problem resolution and ensure outcomes are clearly documented.
  • Leads or supports quality investigations and complaints.
  • complaint management oversight for trending and metrics.
  • Initiate Notification to Management (NTM) as per quality procedures.
  • Support of moderately complex projects either leading or as a participant.
  • Suggest improvements and conduct continuous improvement activities.

Qualifications

Must-Have

  • Bachelor's Degree.

  • 3+ years' experience.

  • Experience in Quality investigations and complaints.
  • Knowledge of current Good Manufacturing Practices and the applicable cGMP regulations and standards.
  • Proactive approach and strong critical thinking skills.
  • Must be able to work in a team environment within own team and interdepartmental teams.
  • Excellent communication, interpersonal and writing skills.
  • Good working knowledge of Microsoft Excel and Word.

Nice-to-Have

  • Master's degree and relevant pharmaceutical experience
  • Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
  • Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure
  • Root cause analysis trained
  • Experience in writing quality reports, complaints, and quality investigations
  • Good questioning skills
  • Experience of quality risk management (QRM) and writing QRM reports

  

PHYSICAL/MENTAL REQUIREMENTS

Office / working from home position.

Requires keen eye and attention to detail

Other Job Details:

  • Last day to apply: August 11th, 2021

  • Eligible for Employee Referral

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

#LI-PFE

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