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location: Norwood, Massachusetts
job type: Contract
salary: $45.00 - 56.77 per hour
work hours: 11 to 7
education: Bachelors
responsibilities:
In this role, you will support QC Bioassay Labs with review of test records and documents.
- Review executed QC test records for molecular and cell based assays
- Review Audit trails
- Review reagent and equipment logbooks
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
- Additional duties may be assigned.
qualifications:
- STEM degree with 5 years of experience in a cGMP laboratory setting, with hands-on experience in molecular biology and cell-based assays (e.g. qPCR, sequencing, potency, mammalian, and bacterial cell culture)
- Previous experience reviewing data in GMP environment for GDP/GMP compliance as well as audit trail review
- Previous experience using Labvantage LIMS and LES worksheets
- Excellent communication skills (verbal and written)
- Working knowledge of USP, ISO, FDA and ICH guidelines
- Experience with laboratory information systems
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Working knowledge of Data Integrity principles and Good Documentation Practices
skills: Quality control, Cell Biology, 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.
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.
