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Specialist, QC Chemistry
15 hours ago
Job Summary
The company is seeking a highly motivated and detail-oriented Quality Control Specialist to lead our growing QC Sample Management function. This individual will serve as a subject matter expert for cGMP sample lifecycle activities while actively contributing to hands-on lab operations and leading a team of associates.You will work at the intersection of science, digital systems (such as LabVantage LIMS), and continuous improvement. The role includes broad exposure to analytical chemistry, microbiology, bioassay, and raw material testing workflows and offers the opportunity to interface with digital transformation projects, including those involving AI tools in the lab data lifecycle.
location: Norwood, Massachusetts
job type: Contract
salary: $ per hour
work hours: 9 to 5
education: Bachelors
Responsibilities
- Lead a team of QC Sample Management Associates supporting Chemistry, Microbiology, Bioassay, and Raw Materials workflows from CMOs and Development labs.
- Oversee and coordinate the daily schedule to ensure timely sample processing, compliance documentation, and lab record completion.
- Create weekly schedules and lead team meetings to align on operational goals and address troubleshooting needs.
- Partner with Digital teams to expand and optimize the use of LIMS (LabVantage), with a pathway to incorporate next-generation data tools including Generative AI in QC workflows.
- Act as primary support for audit readiness and participate in both internal and external inspections.
- Author and revise SOPs, quality records, deviations, CAPAs, and change controls.
- Oversee hiring, onboarding, development, and performance reviews for Sample Management Associates, including 1:1 coaching.
- Maintain compliance of training records for the team and assign appropriate training modules.
- Lead investigations and resolution of compliance issues related to sample handling.
- Manage controlled temperature unit (CTU) systems, including maintenance and troubleshooting.Foster a culture of safety and compliance in the lab environment.
- ou will be responsible not only for the execution of sample management activities but also for building and evolving the systems that support them-demonstrating accountability for both people and processes.
- In this role, you will help drive LIMS optimization and connect with broader initiatives that enable digital QC and data automation, unlocking potential for advanced analytics and AI-enhanced compliance tracking.
Qualifications
Required:
- BA/BS in a relevant scientific discipline with a minimum of 3-5 years of Quality Control experience in a cGMP organization OR MS in a relevant scientific discipline with a minimum of 1-3 years of Quality Control experience in a cGMP organization
- Demonstrate ability to effectively and independently prioritize, manage, and complete multiple projects and tasks in a fast-paced environment
- Detailed knowledge of LIMS system (LIMS) and quality document system (Veeva)
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Experience with gowning, aseptic technique and general lab safety practices
- Flexible schedule to support periodic on call, weekend or holiday coverage
- Strong and effective people management skills
skills: Chemistry, Laboratory Information Management Systems (LIMS), Aseptic Technique, Veeva Vault, Good Manufacturing Practices (GMP)
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
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: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (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.
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