Product Quality Specialist

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world‑class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world.

• Perform Quality Assurance activities associated with commercial products, ensuring accuracy and integrity of all data.
• Provide Quality guidance and expertise to facilitate product changes and issue resolution.
• Provide support to Technical Services, Operations, and Materials Management groups to promote continuity of product lifecycle management.
• Review and approve product and/or equipment-related documents, including specifications, test methods, master and executed batch records, process validation, equipment qualification, change control documents, CAPA, investigations, deviations, regulatory submissions, and stability protocols.
• Investigate client/customer complaints and ensure internal gaps are addressed through the CAPA process, as necessary.
• Assist in client audits and regulatory inspections.
• Contribute to the compilation, review, approval, and reporting of Annual Product Reports.
• Perform batch record reviews and product disposition of finished product during product development, internal commercial operations, and/or external commercial operations.
• Stay abreast of national and international industry and regulatory trends relating to quality; ensure that BPI systems are administered in compliance with those policies and regulations providing subject matter expertise.
• Review and provide input to department operational procedures and practices pertaining to compliance with corporate standards, quality systems, SOPs and cGMPs.
• Collect data for department metrics.
• Work directly with clients to update or revise Quality Agreements, as necessary.
• Perform any other duties assigned by department management.

Reasonable accommodations will be made to enable individuals with disabilities to perform essential functions.

A Bachelor’s degree and 4+ years’ experience required in a GMP-related industry (Pharmaceutical or Medical Device) with a minimum of 2+ years of experience in Quality Assurance or Quality Control.

Broad working knowledge of Quality Systems (e.g. CAPAs, Change Controls, investigations) required and familiarity with 21 CFR 211 preferred.

Excellent interpersonal, organizational, typing and proofreading skills required.

Ability to work independently or in a team; perform detailed work; work under tight time constraints.

Ability to prioritize work for self and influence others for action as required.

Strong computer skills required (knowledge of word processing, spreadsheet and database software recommended).

Knowledge of SAP or other ERP software strongly recommended.

$74,000 - $95,000

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer contributions
• Paid time off and flexible work arrangements
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or childbirth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.