7 days old

Quality Control Cell

Pfizer
Andover, MA 01810
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**ROLE SUMMARY**



The qualified candidate will provide support for analytical method testing in a cGMP quality control analytical (QCA) laboratory. This includes analytical testing support for multiple products including plasmid DNA, vaccines, mAbs, and proteins. The testing includes various techniques including Cell Culture, Bioassay, UV spectrophotometry, and ELISA methods.



This position requires working collaboratively with the QCA team and actively participating in scheduling, visual management, metrics, and continuous improvement activities.



**ROLE RESPONSIBILITIES**



+ Perform and Support lab testing of in process, release and stability samples: execute testing, review data and documents for compliance and accuracy. Support laboratory investigations.

+ Support assay troubleshooting and look for CI opportunities/method improvements.

+ Identify technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct.

+ Maintain all related data and records in compliance with cGMPs and quality procedures.

+ Perform laboratory support functions and maintain work area in compliance with cGMP and quality procedures.

+ Collaborate with site functional areas and customers to support site goals and objectives and transfer timelines.

+ Meet all timelines and deliverables in support of Andover gene therapy manufacturing.



**BASIC QUALIFICATIONS**



+ Bachelor's Degree in Biology, Cell Biology, Immunology or related scientific discipline with 3+ years of relevant laboratory experience required, OR

+ Master's Degree in Biology, Cell Biology, Immunology or related scientific discipline with 2+ years of relevant laboratory experience required

+ Knowledge of various analytical techniques and practical application of relevant analytical techniques (analytical testing and troubleshooting)

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

+ Strong verbal, written communication and technical writing skills



**PREFERRED QUALIFICATIONS**



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

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

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



**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.



**Additional Job Details:**



+ Referral Bonus Eligible

+ \#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



\#LI-PFE
Posted: 2021-02-17 Expires: 2021-03-20
Sponsored by:
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Quality Control Cell

Pfizer
Andover, MA 01810

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