Senior Associate, QA
Company: Sun Pharma (Taro Pharma)
Location: Billerica
Posted on: October 26, 2024
Job Description:
Job SummaryPerforms 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 EstimateUp 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/GLPFundamental knowledge of
chemical principles and analytical instrumentationProficient 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 programsExperience with
qualitative and quantitative analysis using good analytical
laboratory practicesProficient 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. -
Keywords: Sun Pharma (Taro Pharma), Billerica , Senior Associate, QA, Other , Billerica, Massachusetts
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