The company is seeking a highly motivated individual with strong organizational skills to join us as a Quality Control Analytical Associate II. This position provides Quality Control qualification, validation, testing support for cell therapy products. Looking for strong GMP background with method validation and quality control testing experience.
location: Westborough, Massachusetts
job type: Contract
salary: $40 - 47 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Perform routine in-process and release QC testing of cell products.
- Execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and troubleshooting.
- Execute GMP analytical assays such as Immunofluorescence, Flow Cytometry, PCR, Viability, Cell growth and various parenteral assays (Visual Appearance, Content Uniformity, pH, Osmolality).
- 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.
- Support validation and testing of cell bank programs.
- Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability.
- 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. Address 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.
qualifications:
Required
- BS degree with 3+ years or MS with 0-2 years of laboratory 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.
- 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 Validation of Analytical Test Methods
- GMP Cell Culture experience and Environmental Monitoring
- Experience with JMP software and data tracking/trending analysis
skills: Quality control, SOP, CAPA, Flow Cytometry, Cell Cultures, GMP (Good Manufacturing Practice), Polymerase Chain Reaction (PCR)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
