QC Scientist I
- Employer
- Pfizer
- Location
- Andover, Massachusetts
- Start date
- Jul 30, 2021
View more
- Discipline
- Quality, Quality Control, Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Best Places to Work
ROLE SUMMARY
This colleague performs microbiological assays within the Quality Science and Technology group, and interprets results and designs/performs microbiological validation assays involving commercial in-process cell culture, purification and bulk drug substance samples, raw materials, and process & cleaning validation samples. Experience with molecular based techniques, including PCR-based assays is a plus. 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.
ROLE RESPONSIBILITIES
- Performs all work in compliance with cGMPs and site requirements.
- Perform microbiological assays for routine testing and qualification/validation of new methods.
- Support product method improvements, troubleshooting for 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.
- 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.
BASIC QUALIFICATIONS
- Bachelor’s degree in Microbiology or related field required.
- 0 - 2 years of relevant experience required.
- Knowledge and practical application of relevant techniques – classical microbiology techniques required.
- Demonstrated ability to independently document and troubleshoot methods .
- Proficiency with Labware LIMS, MS Word and Excel.
PREFERRED QUALIFICATIONS
- cGMP experience is strongly preferred.
- Novel rapid microbial technologies such as PCR or rapid bioburden desired.
- Experience with technical writing, such as scientific reports, technical papers, method validation reports, etc. a plus.
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:
- Last Date to Apply for Job: 12 AUGUST 2021
- Eligible for Relocation Assistance: NO
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