12 days old

Quality Control Cell

Pfizer
Andover, MA 01810
**ROLE SUMMARY**

The qualified candidate will provide bioassay testing support for new product analytical method transfers and routine testing in a Current Good Manufacturing Practices (cGMP) quality control analytical (QCA) laboratory. The testing utilizes various cell-based techniques including flow cytometry and plate-based bioassay. The candidate will also be expected to support other QCA business activities, as needed.



**ROLE RESPONSIBILITIES**



+ Collaborate with site functional areas such as analytical research and development, quality and manufacturing operations to support site plan of record

+ Perform laboratory testing in support of transfer protocol execution: author test methods, train analysts, review data and documents for compliance and accuracy

+ Perform bioassay testing on drug substance and drug product samples

+ Meet all timelines and deliverables in support of tech transfer and Andover plan of record

+ Perform audit support for board of health inspections and regulatory responses

+ Identify basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and perform method troubleshooting

+ Participate in investigations for root cause analysis, resolution and correction

+ Support installation and/or sustainability of Integrated Manufacturing Excellence (IMEx) elements within the group

+ Contribute to a continuous improvement culture within the group using continuous improvement tools

+ Support change controls and instrument validation



**BASIC QUALIFICATIONS**



+ Bachelor's Degree in Biology, Cell Biology, Immunology or related scientific discipline with 6+ years of relevant laboratory experience required, OR

+ Master's Degree in Biology, Cell Biology, Immunology or related scientific discipline with 4+ years of relevant laboratory experience required

+ Strong understanding of cell biology and molecular biology

+ Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)

+ Strong verbal, written communication and technical writing skills

+ Demonstrated leadership skills in decision making, planning and prioritization with a focus on team success in meeting defined metrics and timelines



**PREFERRED QUALIFICATIONS**



+ Preferred laboratory experience with cellular assays includes flow cytometry, bioassay, aseptic technique and ELISA

+ Prior experience with cell culture transfection preferred

+ Prior work experience in a cGMP environment strongly preferred; knowledge and understanding of cGMP and industry standards

+ Experience with regulatory guidance and audits preferred

+ Strong understanding of continuous improvement tools and skills preferred (standard work, visual management, DMAIC)

+ Experience with BD FACS data management software is a plus



**PHYSICAL/MENTAL REQUIREMENTS**

Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.).



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

Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations or to maintain appropriate social distancing.



**Other Job Details:**



+ **Last Date to Apply for Job: 29 OCTOBER 2020**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus

+ \#LI-PFE



**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

Categories

Posted: 2020-10-13 Expires: 2020-11-18

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Quality Control Cell

Pfizer
Andover, MA 01810

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