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Senior Associate, Quality Assurance
4 months ago
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
- QC Testing data review of 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%
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.
The presently-anticipated base compensation pay range for this position is $98,000 to $119,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees 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 the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice To Agency And Search Firm Representatives
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
