Quality Assurance Team Lead
5 days ago
Job Summary:
">- We are seeking a highly skilled Senior Associate, Quality Assurance to join our Prostaff Solutions LLC team.
About the Job:
This role involves quality assurance review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology.
Responsibilities:
- Review QC Testing data for products, raw materials, stability lots
- Oversee and continuously improve FDA / regulatory compliant Quality System for QC laboratory system
- Plan, direct and coordinate QC batch record review, logbook review, QC test review, and lot disposition activities
- Support any regulatory inspections or internal/external audits
- Perform review of release, stability, validation, analytical quality control tests on raw materials, in-processing and final products
- Conduct, document and follow up on OOS and OOT and Out of Calibration investigations
- Conduct, document and follow up on Lab Events
- Review calibration, monitor and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)
- Review IQ/OQ and PQ protocols for analytical instruments
- Maintain laboratory in cGMP compliance and conduct inspections and internal audits
- Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required.
- Serve as a leader within the QC group and as a knowledge resource (data review, electronic review, data integrity, GDP) within the company
- Any Other duties as assigned
Work Conditions:
- Office
- Lab
- Noise, heat, open flame and radiation in specific areas requiring appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
- Work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases and radioactive materials.
- Exposure to or use of syringes and needles
Physical Requirements:
- Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
- Close vision
- Lift up to 10 lbs.
- Operates Computer/office machines
Travel Estimate:
Up to 5%
Qualifications:
- B.S. or equivalent experience
- Minimum 5-7 years of related experience
- Working knowledge of cGMP/GLP
- Fundamental knowledge of chemical principles and analytical instrumentation
- Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
- Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting)
- Competent computer skills including Microsoft Office and instrumentation control software programs
- Experience with qualitative and quantitative analysis using good analytical laboratory practices
- Proficient in use of Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter,, pH Meter, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Infrared (IR), Gamma Ray Spectrometer, Flame Atomic Absorption (AA), Scanning Ultraviolet/Visible (UV/VIS) Spectrometer, Polarograph, Coulometer, High Pressure Liquid Chromatography (HPLC), and Gas Chromatography.
- Excellent oral, written and interpersonal communication skills
- Ability to follow specific instruction (i.e. written SOPs)
Our Salary Package:
$85,000 - $115,000 per year, based on qualifications and location.
About Us:
At Prostaff Solutions LLC, we pride ourselves on providing top-notch staffing solutions to meet the unique needs of our clients.
Benefits:
We offer a competitive benefits package for eligible candidates, including medical, dental, and vision coverage, 401(k) matching, and paid time off.
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