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location: Rockville, Maryland
job type: Contract
salary: $42.00 - 44.44 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Perform and document routine testing duties including: GMP potency testing of drug substance and drug product samples for product release and stability; potency comparability and non-GMP studies; testing of manufacturing growth medium components for raw material release; testing by qPCR (for Minute Virus of Mouse), ELISA (for identity, residual host cell protein, residual DNA and residual protein A), cIEF (for identity) Biacore (for identity and binding), SDS-PAGE and Western (for identity and purity). May assist in assay development and optimization activities
- Assist with critical reagent and method qualifications, method validation/transfer, lab investigations and assay troubleshooting.
- Operate and maintain QC laboratory equipment and instruments in a cGMP-compliant manner.
- Work through obstacles; perform and complete routine assignments according to written procedures with supervision.
- Perform laboratory duties and safety checks following all safety, GMP, CFR and other regulations in order to assure laboratory compliance.
- Evaluate laboratory SOPs and recommends improvement opportunities to maintain compliance with corporate and regulatory guidelines. Revise laboratory SOPs and Work Instructions as assigned.
- May participate in the on-call response team for chamber excursions, train as a Self-Inspector Auditor and participates in department Self Inspections and assist with reference standard fill.
qualifications:
- Experience in GMP space working in a lab but specifically PCR Assay
- Entry Level Experience 0-1 years in a lab GMP practices
- Shift as some weekend expectations so must be flexible
- BA Degree in biology, biochem, chemistry
- qPCR experience, PCR Assay, lab experience **Preference**
- Will be trained so must be willing to learn.
skills: PCR, Biology, Chemistry, 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.