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location: Norwood, Massachusetts
job type: Contract
salary: $25.00 - 36.65 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Moderna is seeking a contract role in Quality Control Sample Management Associate I based at their Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.
- Sample coordination including cross functional collaboration with internal and external labs
- Receipt, processing, distribution and shipment of the following sample types:
- In-Process
- Equipment Cleaning
- Release
- Stability
- R&D Samples
- Coordinating domestic and international sample shipments
- Communication with external QC and Contract Test Labs (CTLs)
- Interact with Development teams in a GMP compliant manner
- Inspect retention samples
- LIMS (LabVantage) sample logging and update
- AQL visual inspection of drug product
- Stability program support
- Support controlled temperature unit (CTU) management, maintenance, troubleshooting and alarm response.
- Comply with clean room gowning and organization
- Managing/stocking of QC lab supplies
- 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 (GDP) 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
- Maintain a safe laboratory working environment
- Additional duties as may be assigned from time to time.
qualifications:
- Education: BS or MS in a relevant scientific discipline, preferred
- Experience: A minimum of zero to one years, Quality Control experience in a cGMP organization
- Demonstrated aptitude to learn in order to gain a strong understanding of GxP regulations.
- General laboratory operations (Pipette and analytical balance use.)
- Good technical writing skill
- Proficiency with Microsoft Office Programs
- Quick learner with electronic databases (e.g. LIMS, SAP, LMS)
- Good written and oral communication skills as well as organizational skills
- General knowledge of industry standards and guidelines for quality control laboratory operation
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Be able to follow the relevant Standard Operation Procedures as written.
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
skills: Quality control, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
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.
