Pfizer

Quality Control Scientist III, Laboratory Support

Posted on: 6 Feb 2021

Andover, MA

Job Description

ROLE SUMMARY

Pfizer is seeking a talented individual to join our Quality Control Analytical (QCA) or Quality Control Raw Material (QC RM) team in Andover, MA. As an experienced member of the Quality organization, you will work outside the lab providing technical and documentation support, oversight of testing and scheduling and troubleshooting support. You will also serve as a backup to the lab manager. You will be assigned a primary lab/product of focus, but may flex to support other areas, as needed. Products include: plasmid DNA, vaccines, mAbs, proteins and raw materials.

If you have experience working in a Quality Control laboratory, have strong technical writing and troubleshooting skills, and want to support a lab from a non-testing perspective, then this position may be for you.

ROLE RESPONSIBILITIES

As a Quality Control Scientist III, Laboratory Support, you will provide non-testing support for your assigned lab/product. You will:

* Support lab testing including assisting with assay troubleshooting, tracking testing and timelines, and reviewing data and documents for compliance and accuracy.
* Maintain cGMP compliance and laboratory inspection readiness.
* Provide audit support for board of health inspections and regulatory responses.
* Drive and provide technical expertise for investigations, technical documents, test methods and Annual Product Quality Reviews (APQRs).
* Support change controls, audits and commitments.
* Provide back up support for the lab manager.
* Identify, drive and participate in continuous improvement activities.
* Participate in cross-functional teams.

The successful candidate will be a proven QC Scientist with deep laboratory experience, strong technical writing skills, ability to convey technical concepts to others, have a passion for continuous improvement, and enjoy providing subject matter expertise and support to fellow colleagues.

BASIC QUALIFICATIONS

* Bachelor's Degree in Biology, Chemistry or related discipline required.
* 3-5 years of applicable laboratory experience required.
* Knowledge of analytical techniques include HPLC, Capillary Gel Electrophoresis, Peptide mapping and UV Spectrophotometry.
* Extensive knowledge and practical application of relevant analytical testing and troubleshooting.
* Strong technical writing skills, including investigations.
* Experience with cGMPs, regulatory guidance and audits.
* Demonstrated leadership skills in decision making, planning, and prioritization with a focus on team success in meeting defined metrics and timelines.
* Strong troubleshooting skills.
* Self-motivated and able to adapt to rapidly changing project priorities.

PREFERRED QUALIFICATIONS

* Knowledge in ELISA and Bioanalytical method preferred.
* Project management skills.
* Experience with continuous improvement tools including standard work, visual management, and 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.

Other Job Details:

* 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 providers 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

Pfizer

New York, New York

Pfizer Inc. develops, manufactures, and sells healthcare products worldwide. It offers medicines and vaccines in various therapeutic areas, including internal medicine, vaccines, oncology, inflammation and immunology, and rare diseases under the Lyrica, Chantix/Champix, Eliquis, Ibrance, Sutent, Xalkori, Inlyta, Xtandi, Enbrel, Xeljanz, Eucrisa, BeneFix, Genotropin, and Refacto AF/Xyntha brands. The company also provides consumer healthcare products that comprise over-the-counter medicines, including dietary supplement products under the Centrum, Caltrate, and Emergen-C names; pain management products under the Advil and ThermaCare names; gastrointestinal products under the Nexium 24HR/Nexium Control and Preparation H names; and respiratory and personal care products under the Robitussin, Advil Cold & Sinus, and ChapStick names. In addition, it offers products that would lose or have lost marketing patent protection; branded generic products; generic sterile injectable products; biosimilars; and anti-infectives under the Lipitor, Premarin family, Norvasc, Lyrica, Celebrex, Viagra, Inflectra/Remsima, Zyvox, Vfend, Revatio, Inspra, Medrol, Sulperazon, Fragmin, Tygacil, Nivestim, and Retacrit, Ixifi Infliximab BS names.

Further, the company is also involved in the contract manufacturing business. It serves wholesalers, retailers, hospitals, clinics, government agencies, pharmacies, and individual provider offices, as well as disease control and prevention centers. The company has collaboration and/or co-promotion agreements with Bristol-Myers Squibb Company, Astellas Pharma US, Inc., and Oncolytics Biotech Inc.; licensing agreement with BionTech AG; strategic alliance with Verily Life Sciences LLC; and collaboration agreements with Pfizer, Merck & Co., Inc., and Eli Lilly & Company, as well as with Merck KGaA and Nektar Therapeutics to develop a therapy for treating pancreatic cancer. Pfizer Inc. was founded in 1849 and is headquartered in New York, New York.

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