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The Senior Specialist, Lab Services is responsible for planning, coordinating, and/or implementing initiatives that provide quality assurance support for QC Lab Operations. Specific areas of support may include:

GMP/Compliance; Change Management, Lab Equipment/Instrument procurement, installation, calibration, validation/qualification, Training and other QC Lab support projects.

This position will help to ensure that the QC Labs operate in compliance with corporate and governmental regulations.

Top 3-5 skills, experience or education required

1. GMP Lab Experience 6+ years

2. Documentation Review

3. Empower

4. LIMS

5. Electronic Lab Notebook

Responsibilities :

+ Serve as compliance specialist for the QC lab including routine assessment of lab compliance, monthly communication to lab management regarding compliance concerns, ensure lab managers complete quarterly LIR and data review checklists, and serve as coordinator for any lab specific audits as needed.

+ Coordinate lab review of compendial changes to evaluate impact and assign verification testing as needed.

+ Serve as calibration coordinator for lab including approval and scheduling of service requests, impact assessment of demand maintenance on instrument qualification status, assignment, review, and approval of instrument related investigations, and creation of work orders in Maximo to capture vendor visits/maintenance as well as adding new instruments and decommissioning old instruments as needed.

+ Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated and qualified according to company procedures.

+ Perform assessments of QC documents (i.e. methods, qualification protocols, calibration documents, etc.) to determine compliance to processes and regulations to identify potential gaps. Mitigate and implement

+ improvements within the quality system.

+ Lead project teams in planning, preparation, review, and approval of quality documentation related to calibration requests.

+ Participate on validation review board as area validation for equipment qualifications.

+ Assist in the design of effective quality systems, procedures, and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.

+ May be asked to assist in development, revision, or implementation (including delivering training) of training modules, videos, and documents to the local and to global labs.

Qualifications :

+ Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred.

+ 4+ years’ experience in quality assurance, quality oversight or relevant experience.

+ Knowledge and familiarity with product testing, test method requirements, and capabilities of common lab instrumentation is preferred.

+ Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.

+ Experience leading teams to deliver tactical results.

+ Strong oral and written communication skills.

+ Good interpersonal skills.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.