3 days old

Quality Assurance Associate

Pfizer
Sanford, NC 27330
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**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 an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming 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**



+ 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.

+ Create, review and approve Good Manufacturing Practices {also cGMP} audit reports.

+ Review and approve Manufacturing and Packaging records to ensure that the information and documentation conforms to Pfizer policy and cGMP's.

+ Create, review and approve deviations and consistently produce quality work.

+ Accurately communicate supply, operational needs or Quality Operations (QO) perspectives and escalate issues with potential market or stability impact.

+ Ensure that all documents received in the batch release area reviewed for completeness and accuracy.

+ Provide Real Time Quality impact assessments and decisions on product and medical device issues, independently.

+ Maintain inspection readiness, support inspections from regulatory agencies & customers and improve quality assurance systems.

+ Participate in Green/Black belt projects, Right First Time (RFT) Improvement projects, Corrective Action / Preventative Action Effectiveness, etc. as appropriate.

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

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

+ Lead/Participate in Quality Risk Management (QRM) assessments that gain approval through Site and Area Quality Operations (QO) Management.



**BASIC QUALIFICATIONS**



+ Bachelor's degree in Science, Engineering, Mathematics, English, Communications, Business or related field, with at least 1 year's worth of experience, preferably in a Biopharmaceutical or other regulated environment.



OR



+ AS in Science, Engineering, Mathematics, English, Communications, Business or related field, with a minimum of 3 years' worth of experience, preferably in a Biopharmaceutical or other regulated environment.



OR



+ A minimum of 5 years' worth of experience in a documentation-related or supporting function preferably in a Biopharmaceutical or other regulated environment.



**PREFERRED QUALIFICATIONS**



+ Able to quickly learn and navigate electronic systems to facilitate routine operation and maintenance of the site documentation system and related processes

+ Able to write clearly and concisely with excellent grammar, good writing skills and communication

+ Skilled in word processing and document formatting; experienced in Microsoft Office applications (Word, Excel, PowerPoint, Visio)

+ Able to effectively proofread documents prepared by self and others for content and others to ensure content and formatting accuracy

+ Demonstrates an ability to adapt to shifting priorities, change, stress and to find appropriate balance between needs of the organization, others and self. Incorporates insights of other people into ongoing work.

+ Able to learn and understand pharmaceutical processes in order to assist with training needs

+ Understanding of cGMP and Safety regulations

+ Strong organizational and communication skills

+ Team based collaborative problem solving



**PHYSICAL/MENTAL REQUIREMENTS**



Position requires desk work and some walking throughout campus to interface with other departments.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



May require occasional evening and weekend hours, as indicated by business and customer needs.



**OTHER JOB DETAILS:**



+ Last day to apply 6/16/2021

+ Employee Referral Bonus eligible



**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
Posted: 2021-06-11 Expires: 2021-07-12
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Quality Assurance Associate

Pfizer
Sanford, NC 27330

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