Website Mindlance
Mindlance
Company : Mindlance
The top 3-5 skills:
1. Experience with chamber and autoclave qualification/mapping
2. Bachelor s degree in biology, microbiology, engineering, or other technical/scientific area
3. Knowledge of QA systems and GxP compliance requirements
4. Ability to work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated, and qualified.
Purpose:
The Specialist, Lab Services may be 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; 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:
" Draft and execute IQ/OQ/PQ qualifications for temperature, temperature and humidity-controlled chambers, and autoclaves.
" Work collaboratively with multiple parties to ensure appropriate instrumentation is procured, installed, calibrated, and qualified. Ensuring each aspect of the process is compliant with Corporate and governmental regulations
" Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within the quality system.
" Support the QC Labs to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
Qualification:
" Bachelor s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/ scientific area preferred.
" 3+ years experience in quality assurance, quality oversight or relevant experience.
" Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.
" Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device, biologics, and pharmaceutical products preferred.
" Strong oral and written communication skills.
" Good interpersonal skills.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.