QC Lab Operations; Data Integrity Specialist III

Data Integrity Specialist III (QC Lab Operations)

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$30.00/hr - $33.00/hr

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Duration: 6 months

Description:

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.

Responsibilities:

• Serve as compliance specialist for the QC lab including routine assessment of lab compliance, monthly communication to lab management concerning 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 proc-ġer, 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.

Skills:

• 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 standard affecting device, biologics, and pharmaceutical
  products preferred.
• Experience leading teams to deliver tactical results.
• Communication and interpersonal skills.
• GMP Lab Experience of 6+ years.
• Documentation Review.
• Empower.
• LIMS
  .
• Electronic Lab Notebook (
  ELNs
  ).

Education and experience:

• 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 убточ

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

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.

Recruiter Details:

Name:
Shivangi Shivpuri

Email: shiv

Internal
-00584

Mid-Senior level

Contract

Manufacturing, Research, and Science

Pharmaceutical Manufacturing, Manufacturing, and Biotechnology Research