1+ months

QC Scientist II

Andover, MA 01810

The qualified candidate must have the experience and ability to participate in multiple projects within the Quality Science and Technology group. The candidate will be responsible for performing primarily laboratory related tasks, including but not limited to testing for clinical/commercial in-process cell culture, purification and bulk drug substance validation samples and raw materials; data review, protocol/report writing, design notebook studies (with guidance), and attending meetings as needed. Demonstrates the ability to interpret results.


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

+ Performs traditional microbiology testing (bioburden and LAL) in support of commercial product investigations, method improvements, troubleshooting etc.

+ Perform validation of bioburden and endotoxin (LAL) methods and sample hold time during process validation for new products and raw materials.

+ Recognizes atypical or out-of-specifications test results, instrument malfunctions and methodology problems and assists in the investigation to resolve and correct.

+ Designs assays and experimentation, with guidance, in support of contamination investigations; has a general understanding of study design

+ Accountable for the accuracy and validity of testing results. Reviews validation data. Interprets results, performs or reviews mathematical calculations. Ensures that technical reports are prepared in a timely manner and reviews these reports for technical accuracy and compliance.

+ Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.

+ Highly motivated individual who receives minimal supervision on routine assignments. Demonstrates flexibility and ability to multi-task. Ability to plan and prioritize concurrent assignments/tasks.

+ Capability and desire to work as a team member in a fast paced environment.

+ High level of communication skills with peers and management. Demonstrates a positive attitude.

+ Understands the theory behind the techniques ("hows" and "whys") or is willing to learn.

+ Detail oriented; able to compile data in a clear and understandable format and notice discrepancies, calculation errors, and deviations from test methods and/or acceptance criteria


Bachelor's degree in Microbiology or related field with a minimum of 1-3 years

Knowledge and practical application of relevant techniques - classical microbiology techniques (required) as well as novel rapid microbial technologies such as PCR or rapid bioburden (desired but not required)

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

Demonstrated ability to independently document and troubleshoot methods

Proficiency with Labware LIMS, MS Word and Excel.

cGMP experience is required

**Technical Skills Requirements**

+ Working knowledge of traditional microbiological techniques such as bioburden and endotoxin (LAL) testing

+ Strong understanding of the science behind techniques in order to support special request studies and troubleshoot method related issues

+ Plans and prioritizes concurrent assignment/activities

+ **Last Date to Apply for Job: 05.27.2020**

+ **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: 2020-05-07 Expires: 2020-07-08

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QC Scientist II

Andover, MA 01810

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