Join a Leading Biologics & Cell/Gene Therapy Company! We are seeking several QC Analysts to join a top-tier, biologics and cell & gene therapy company in a dynamic, fast-paced environment.
The Quality Control Technical Transfer Analyst 3 will act as a team member of the Quality Control department to support production by contributing to the completion of the technical transfer activities. Also participate in quality testing for customer in-process, final product testing and stability studies when needed.
Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
location: Portsmouth, New Hampshire
job type: Contract
salary: $28.05 - 33.00 per hour
work hours: 8 to 4
education: Associate
responsibilities:
- Running test samples for In-Process, Lot Release and Stability studies. Testing to include: Capillary Electrophoresis - SDS (CE-SDS), ELISA, UV-Vis, qPCR, etc.
- Running test samples for (but not limited to) investigations, transfers and validations.
- Reviewing assays
- Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
- Projects - such as method transfers, new instruments, method qualifications
- Use of Microsoft Suites (Word, Excel, PowerPoint)
- Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
qualifications:
Required:
- Associate's Degree (AS) Biology, Microbiology, Biochemistry, Cell Biology, Molecular Biology, or Related Science Fields
- Experience with analytical techniques used in biopharmaceutical Quality Control (QC) and characterization testing.
- Strong ability to interpret data both alone and with guidance.
- Experience with any of the following: Absorbance (A280), Capillary Electrophoresis-SDS (CE-SDS), Imaged Capillary Isoelectric Focusing (icIEF), ELISA, SoloVPE (UV-Vis), and qPCR
skills: Molecular Biology, Quality control, Cell Biology, CAPA, Assay Method, Biology, Microbiology, GMP (Good Manufacturing Practice)
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
