Overview
Associate Director, Quality Assurance (hybrid) Jobs in Winston-Salem, NC at Collins Aerospace
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Join the Thermo Fisher Scientific team for impactful work, innovative thinking, and a customer-centric culture.
Location/Division Specific Information
CDD offers diagnostic solutions for IVD market segments and has been a trusted supplier for 40+ years.
Discover Impactful Work:
Middletown, VA team supports top IVD suppliers as OEM/contract manufacturer, trusted for 35 years.
A day in the Life:
Lead and run a Quality Control team responsible for raw material management and product release testing.
Redesign the vision for the QC team based on our evolving and growing business.
Coach, mentor, and develop people and encourage a culture of learning.
Establish QC metrics, data trending, and drive actions for department improvements.
Partner with cross-functional team members to drive and implement critical quality attributes, cross-functional and cross-site initiatives.
Drive the implementation of analytical tools and techniques to ensure robust Quality products.
Position Requirements:
Direct oversight and management of the QC department that includes incoming, in process, and release testing.
Maintain accurate inventory levels of lab supplies, equipment calibration, and staff scheduling in the QC lab.
Provide direct supervision and direction to employees according to established policies and management mentorship.
Work on issues where analysis of the situation or data requires review of relevant factors and exercises judgement based on procedures/policies to determine appropriate action.
Establish and manage QC metrics, data trending, and drive actions for department improvements.
Ensure accurate training of all staff regarding testing, instrumentation, and methodologies.
Contribute to Development, Updating, and/or review of Test Procedures, SOPs, and Protocols as assigned.
Guide the team on approach to risk assessment of methods transferred from clients, test method transfer, verification/qualification and validation of test methods.
Perform troubleshooting and investigations of instruments and product-related OOS.
Align with all regulatory/in-house requirements (may include but is not limited to safety, housekeeping, laboratory chemical waste, cGMP, GDP, documentation) when performing the assigned activity.
Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Education/Qualifications:
Degree or equivalent experience in Biochemistry, Microbiology, Molecular Biology, Pharmaceutical Sciences, or related field.
7+ years Biotech experience within regulated industry.
5+ Years of experience managing QC team.
Experience in a cGMP environment is required.
Knowledge and use of Good Documentation practices is required.
Ability to learn quickly and make sound, scientifically driven decisions that adhere to regulatory practices is required.
Experience with internal, external, and customer audits.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Apply today! http://jobs.thermofisher.com
Accessibility/Disability Access
Thermo Fisher Scientific provides accessibility services for job seekers needing accommodations in the application process. This may involve help for hearing, vision, mobility, or cognitive challenges.
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Title: Associate Director, Quality Assurance (hybrid)
Company: Collins Aerospace
Location: Winston-Salem, NC
