Job Title: QC Associate II
Location: Westborough, MA
Zip Code: 01581
Duration: 12 Months
Pay Rate: $48/hr
Keyword's: #Westboroughjobs; #Associatejobs.
Start Date: Immediate
Job Description:
Essential Job Responsibilities:
* Perform routine in-process and release QC testing of AIRM cell products.
* Execute GMP analytical assays such as Immunofluorescence, Flow Cytometry, PCR, Viability, Cell growth and various parenteral assays (Visual Appearance, Content Uniformity, pH, Osmolality).
* Perform analytical method qualifications, validations and transfers including drafting technical protocols, reports and assay troubleshooting.
* Maintain, calibrate and operate GMP equipment and instruments supporting QC testing.
* Track and test products according to stability protocols.
* Culture and maintenance of cell lines and stem cells.
* Work with internal and external resources to maintain lab in a GMP state.
* Monitor and trend QC data.
* Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stablity.
* Perform shipment of materials for QC testing to contract labs and perform data review.
* Author, revise and review SOPs, qualification/validation protocols and reports.
* Conduct investigations regarding out of specifications (OOS) results. Assist and manage deviations and CAPAs related to analytical procedures.
* Monitor the GMP systems currently in place to ensure compliance with documented policies.
* Perform QC lab duties and technical projects as required.
* Quantitative Dimensions: This position interacts with Quality Control, Analytical Development, Drug Product Development, Manufacturing and Quality Assurance. Will contribute to the development of QC departmental processes.
* Organizational Context: Reporting to QC Scientist I Terrence Tamakloe
Qualifications:
* Bachelors degree in biotechnology or related field with 3+ years of Quality Control experience, or a Master"s degree in biotechnology or related field with 0-2 years of Quality Control experience.
* Relevant GMP experience in the quality control department of a biotech and/or pharmaceutical industry.
* Ability to work weekends is required; while most of the schedule will be during a standard work week, there will be regular weekend work.
Preferred
* Experience with relevant analytical test methods: including PCR, Flow Cytometry, IFA and cell based assays
* Experience with ICH guidelines and parenteral test methods
* Experience with 21CFR Part 11 Compliance
* Experience with the qualification of Analytical Test Methods
* GMP Cell Culture experience and Environmental Monitoring
* Experience with data tracking/trending analysis