Quality Assurance Specialist jobs in Santa Clara, CA

Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving peoples lives with our health care products.

The Senior Quality Assurance Specialist provides Quality support for Petaluma site and ensures adherence to cGMP compliance in a regulated environment. This position also works with external contract manufacturer’s and laboratories.

Key Activities:

· Review and approve GMP documents (e.g., production batch records, clinical labelling records, lab batches, API and raw material specification, drug product specifications, analytical work order reports, standard test methods, standard operating procedures, protocols for method validation, method validation reports, stability protocols and stability reports, equipment IQ, OQ, PQ qualification protocols and reports, and equipment calibration documentation).

· Review and approve deviation and OOS investigations.

· Review and approved method transfers.

· Facilitate GMP product readiness and launch activities, including stability strategy, technology transfer and validation.

· Ensure timeliness and integrity of work.

· Understand technical procedures and be able to verify accuracy of calculations.

· Support new product development and CMO activities for pharmaceutical products.

· Review and release clinical trial materials manufactured on site or externally.

Qualifications:

· 5 years pharmaceutical industry experience.

· Strong technical experience in a cGMP pharmaceutical setting.

· Experience implementing, maintaining and improving quality systems, including SOP writing.

· Bachelor’s Degree in a scientific or engineering discipline, graduate degree a plus or equivalent experience. Experience working in a changing environment and fast-paced organization as a member of cross-functional teams.

· Working in a GMP laboratory environment or manufacturing environment a plus.

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is 90,000 - 100,000.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

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This position may be available in the following location(s): [[location_obj]]

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/6d14a0b2d6ae791286e49cc8358d2a3ef29730f9) .

Bausch Health is an EEO/AA employer M/F/D/V.