Microbiologist II
Billerica, MassachusettsJob Summary:
Perform GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology
Areas of Responsibility:
Record GMP data, monitors and evaluates QC systems and equipment
Implement improvements to procedures, and revises SOP’s and GMP documentation as required
Interact with internal and external auditors including government agencies and contract manufacturing representatives
Perform sterility and endotoxin testing for release, stability, and validation for raw materials, in-process andfinal products
Maintain Sterility and Endotoxin testing areas in a state of cGMP compliance
Perform and review growth promotion testing data for qualification of microbial culture media
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 evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)
Maintain records in paper based or computer based systems
Author and execute method validation/suitability protocols related to product testing
Author summary reports for executed method validation/suitability protocols
Author deviation reports and microbiological assessment reports related to departmental activities and product testing
Review Microbiology testing data as required
Coordinate receipt of raw material, in-process and final product samples for testing
Maintain metrics for receipt and processing of samples for microbiology testing
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
Perform other duties as assigned
Job Qualifications and Experience:
2-4 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
- BS in Microbiology or related field required
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
About Us
Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S. We are the eighth-largest generics pharmaceutical company in the U.S., and we are rapidly ramping up our presence in the specialty branded market, with dermatology, ophthalmology, and oncology as key target segments.
Our Values
Sunology, a combination of Sun and Ideology, is the way of life at Sun Pharma. We practice humility, integrity, passion, and innovation.
How We Work
With people at our core, Sun Pharma has built an inclusive and collaborative work culture, where all employees are empowered to pursue their dreams and professional aspirations.
Benefits
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Health & Wellness
We offer comprehensive benefits, including medical, dental, and vision coverage, as well as health and wellness programs.
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Financial
We provide a competitive 401(k) match program and financial wellness programs to support our employees’ short- and long-term financial goals.
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Life, Work & Family
We provide work-life benefits that support our employees beyond their workday.
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Create Your Own Sunshine
At Sun we empower our employees to be Better Everyday, Take Charge and Thrive Together.
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About Us Learn more
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Career Areas Learn more
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