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location: Norwood, Massachusetts
job type: Contract
salary: $35.00 - 41.84 per hour
work hours: 3 to 11
education: Bachelors
responsibilities:
In this role, you will perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in process samples. This role may support special projects as needed.
- Performs routine analytical chemistry testing including HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, KF, etc.
- Supports special projects as assigned.
- May assist with Troubleshoots assay methods and equipment.
- Performs data entry and supports trending.
- Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
- Supports authoring of SOPs, protocols and reports.
- LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
- Perform HPLC (AEX) and NaOH plate reader based assays in support of manufacturing process stat testing as needed
- Stability program support.
- Support more junior staff with data review, training, and troubleshooting.
- Managing/stocking of QC lab supplies
- Write/revise SOPs, protocols and reports.
- Complete and maintain cGMP documentation for work performed.
- Participate in authoring quality systems records such as investigations, deviations, change controls, CAPAs
- Establish and maintain a safe laboratory working environment.
- 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 as may be assigned from time to time
qualifications:
- Education: BA/BS in relevant scientific discipline
- Experience: 2 years of Laboratory experience.
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
skills: Quality control, HPLC, SOP, CAPA, 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.
