Microbiology Analyst I
Company: Sun Pharmaceutical Industries, Inc.
Location: Billerica
Posted on: October 7, 2024
Job Description:
Job SummaryPerforms GMP testing of raw materials, in-process and
finished products, stability samples, and non-routine sample
analyses per established procedures and methodology. -Area Of
Responsibility -
- Record GMP data, monitor and evaluate QC systems and
equipment
- Recommend improvements to procedures, and revise SOPs and GMP
documentation as required
- Interact with internal and external auditors including
government agencies and contract manufacturing representatives
- Perform release, stability, validation and complaint follow-up
assays on raw materials, in-process and final products
- Perform microbial identification related to product and
environmental testing
- Perform sampling of raw materials as required for QC
testing
- Perform routine quality control testing as required and
monitors or evaluate systems, equipment (i.e. water systems,
environmental chambers, sample collection and testing
instruments/equipment)
- Maintain records in paper based or computer based systems
- Execute method validation protocols related to product
testing
- Author summary reports for executed method validations
- Author deviation reports and microbiological assessment reports
related to departmental activities and product support
- Provide technical input on product testing issues and
instrumentation/equipment
- Serve as liaison to service, calibration and technical
representatives
- Conduct and document assay failure and complaint
investigations
- Ensure that laboratory is in cGMP compliance and conduct
inspections
- Other duties as assigned -Work Conditions: -
- Lab
- Office
- Laminar flow and biosafety hoods
- Exposure to noise, bio-hazardous (live cultures), and
chemicals
- May entail exposure to radiation within NRC limits
- Exposure to or use of syringes and needles
- Exposure to non-hazardous and hazardous chemicals and
materials
- Exposure to biological safety cabinets
- Requires work in class 100K, 10K or 100 clean room (mask and
boots in conformance with environmental dress codes
- Moderate noise, oven heat, open flame, chemical fume hoods
areas requiring wearing appropriate safety equipment (i.e. gloves,
lab coat, safety glasses and respirator) -Physical Requirements: -
- Stand, sit, walk, use hands and fingers to handle or feel,
reach with arms and hands, talk or hear, -stoop, kneel, crouch or
crawl.
- Close vision; -depth perception; ability to adjust focus
- Use of repetitive motion
- Able to operate computer/office machines
- Lift up to 25 lbs. -Travel EstimateUp to 0% - -Education and
Job Qualification -
- BS in Microbiology or relevant experience required -Experience
-
- 0-2 years related experience in a Pharmaceutical/drug (FDA
Regulated) industry preferred
- Experience in pharmaceutical microbiology and microbiology
testing not limited to endotoxin, method validation, sterility,
bioburden, microbial identification, growth promotion and
environmental monitoring testing; ability to perform standard and
non-standard microbiology techniques to analyze product
- Excellent verbal, written and interpersonal communication
skills
- Proficient at following specific instruction (i.e. written
SOPs)
- Working knowledge of cGMP/GLP
- Good computer skills including word processing and working with
spreadsheets - - -The presently-anticipated base compensation pay
range for this position is $78,000 to $95,160. 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. -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, and may be eligible for the
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 Taro employee by a third party
agency and/or search firm without a valid written & signed search
agreement, will become the sole property of Taro. 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 Pharmaceutical Industries, Inc., Arlington , Microbiology Analyst I, Professions , Billerica, Massachusetts
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