19 days old

Quality Control Scientist III

Andover, MA 01810
**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** The qualified candidate must have training and experience with molecular based techniques, including PCR-based assays, isolation of DNA and RNA templates, reverse transcriptase PCR, and qPCR. The qualified candidate must have the experience and ability to perform microbiological assays involving clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements and per standard operating procedures.

The candidate must have the ability to participate in multiple projects and meet aggressive timelines within the Quality Science and Technology and Quality Control Microbiology groups. Participates in instrument validation, as needed, and method validation, primarily in PCR based technologies. The candidate will be able to participate in the interpretation of results and the design of follow-up studies. Candidate will be able to support any deviations or laboratory investigations in support of the PCR based assays. The candidate will be able to represent the Quality Science and Technology and Quality Control Microbiology group at internal meetings and potentially be able to support BOH investigations.

**How You Will Achieve It**

+ Performs all work in compliance with cGMPs and site requirements.

+ Perform PCR-based assays for routine testing and qualification/validation of new methods, or DNA and/or RNA extraction and PCR -based assays, including RT-PCR and qPCR, for the routine testing and qualification/validation of new methods.

+ Support product investigations, method improvements, troubleshooting for PCR-based assays and other assays as needed.

+ Recognizes atypical or out-of-specifications test results, instrument malfunctions and methodology problems and leads the investigation to resolve and correct. Support instrument validation activities.

+ Accountable for the accuracy and validity of testing results. Reviews and validates data. Interprets results, performs or reviews mathematical calculations, and records observations using Laboratory notebooks or other controlled documentation. Ensures that technical reports are prepared in a timely manner and reviews these reports for technical accuracy and compliance. Trains less experienced analysts in new and existing procedures, techniques and governmental regulations. Mentors analysts by providing technical knowledge and support in resolving technical problems.

+ Oversees maintenance of all related records and ensures that laboratory work area is maintained in a neat, orderly, and compliant manner. Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.

+ Support instrument validation activities for Quality Science and Technology, focused on PCR instrumentation.



+ Bachelor's Degree in Microbiology or related field with 5+ years of relevant laboratory experience, OR Master's Degree Microbiology or related field with 3+ years of relevant laboratory experience required.

+ Experience within a cGMP environment required.

+ Knowledge and practical application of relevant techniques (classical microbiology techniques).

+ Demonstrated ability to independently develop, document, validate, and troubleshoot methods with high levels of complexity.

+ Proficiency with MS Word and Excel.


+ Work experience within the biopharmaceutical industry preferred.

+ Knowledge and practical application of novel rapid microbial technologies such as PCR or rapid bioburden preferred.

+ Experience with technical writing, such as scientific reports, technical papers, method validation reports, etc. a plus.

+ Proficiency with LIMS preferred.

**Physical/Mental Requirements**

Position is a mixture of lab and office, approximately 50-75% of the time will be spent in the laboratory. Laboratory duties such as equipment cleaning and maintenance may be required.

**Non-Standard Work Schedule, Travel, or Environment Requirements**

Position is first shift Monday through Friday. Some off Holiday and off hour support may be required to support review and/or testing needs.

**Other Job Details:**

+ 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


Posted: 2020-11-16 Expires: 2020-12-16

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Quality Control Scientist III

Andover, MA 01810

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