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Senior Associate, QA

4 months ago

Billerica MA, United States Sun Pharma (Taro Pharma) Full time

Job Summary

Performs QA review of testing records of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology

 

Area Of Responsibility

  • 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%

Education and Job Qualification

  • B.S. or equivalent experience
  • Excellent oral, written and interpersonal communication skills
  • Ability to follow specific instruction (i.e. written SOPs)

 

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.

 

 

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).