Product Quality Specialist

The Product Quality Specialist will be responsible for providing Quality support to the CDMO product portfolio, inclusive of products in development or site transfers through product discontinuation. Will represent the QA group on relevant project teams (both internal and client project teams) and provides general quality guidance to meet project milestones. Will act as the quality subject matter expert for the commercial and/or development product portfolio and serves as liaison with cross-functional stakeholders and clients to facilitate continuous improvement, change management, and issue resolution.

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

Essential Duties:

• 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 the Technical Services, Operations, and Materials Management groups to promote continuity of product lifecycle management.
• Review and approve product and/or equipment-related documents including, but not limited to, 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.
• Assists in client audits and regulatory inspections.
• Contributes to the compilation, review, approval, and reporting of Annual Product Reports. Performs batch record reviews and product disposition of finished product during product development, internal commercial operations, and/or external commercial operations.
• Stays abreast of national and international industry and regulatory trends relating to quality; ensures 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.
• Any other duties as assigned by department management.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Education/Experience Requirements:

• 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; ability to perform detailed work; ability to 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 data base software recommended).
• Knowledge of SAP or other ERP software strongly recommended.

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees’ wellbeing, including:

• Competitive salary and performance-based incentives

• Comprehensive health coverage including medical, dental, and vision insurance

• Retirement savings plans with employer matching contributions

• Paid time off

• Professional development opportunities

• Employee wellness programs and resources

• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals 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 child birth), 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.