Senior Quality Control Associate Scientist jobs in United States
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MilliporeSigma ยท 1 hour ago

Senior Quality Control Associate Scientist

MilliporeSigma is a global leader in science and technology, dedicated to enriching lives through innovative solutions in Healthcare, Life Science, and Electronics. The Senior Quality Control Associate Scientist is responsible for performing cGMP analytical laboratory analyses and ensuring data accuracy and quality, along with supporting various Quality Control activities. The role involves collaboration, problem-solving, and maintaining laboratory compliance in an audit-ready state.

BiotechnologyMedicalMedical Device
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Responsibilities

Perform analytical testing of cGMP materials (samples, reference standards) and ensure accuracy and quality of data by using proper laboratory techniques and documentation
Assist with training of newer laboratory staff as needed
Performs peer review
Work in a safe manner and ensure the lab stays in an audit ready and clean state
Maintain the laboratory by ordering reagents or supplies, ensuring clean glassware is available, disposing of waste properly, and completing general housekeeping chores
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Exercise judgment within generally defined procedures and practices
Solve problems and make decisions with minimal assistance
Maintain projects and timelines with minimal oversight
Meet with internal project groups to keep projects on track
Perform instrument Performance Verifications (PV) as needed
Manage assigned change controls and CAPAs to ensure on-time completion
Participate in OOS and OOT investigations via testing, good documentation, and assisting with identification of root causes
Assist with writing and revision of SOPs including raw material specifications, intermediate specifications, final product specifications, and stability protocols
Work cooperatively within the QC department and with other departments to achieve project goals
Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210, and 211 as applicable
Support all data integrity initiatives and strive for right first time

Qualification

CGMP experienceHPLCGCMethod validationAnalytical testingTeam collaborationCommunication skillsDocumentation practices

Required

Bachelor's Degree in Biology, Chemistry, Chemical Engineering, or other scientific discipline
1+ years cGMP experience

Preferred

3+ years of experience in a laboratory environment operating under GLP or cGMP conditions
Excellent written, verbal communication skills and excellent documentation practices
Ability to work in a team environment

Benefits

Health insurance
Paid time off (PTO)
Retirement contributions
Other perquisites

Company

MilliporeSigma

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Together with our colleagues, customers and stakeholders, we impact life and health with science.

Funding

Current Stage
Late Stage

Leadership Team

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David Nogales
Head of Technology Strategy
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