Product Quality Specialist

Bora Pharmaceuticals•Maple Grove, MN

About The Position

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. 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.

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).

Nice To Haves

Knowledge of SAP or other ERP software strongly recommended.

Responsibilities

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.