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Microbiologist II

Billerica, Massachusetts

Category Quality Job ID R-46949

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Job 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

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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

Health & Wellness

We offer comprehensive benefits, including medical, dental, and vision coverage, as well as health and wellness programs.
Financial

We provide a competitive 401(k) match program and financial wellness programs to support our employees’ short- and long-term financial goals.
Life, Work & Family

We provide work-life benefits that support our employees beyond their workday.
Create Your Own Sunshine

At Sun we empower our employees to be Better Everyday, Take Charge and Thrive Together.