Performs 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.
Education and Job Qualification
B.S. in Microbiology required
Experience
At least 1-2+ 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 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.
Seniority level
Associate
Employment type
Full-time
Job function
Science and Quality Assurance
Industries
Pharmaceutical Manufacturing
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