Sr. Product Quality Specialist

Bora Pharmaceuticals•Maple Grove, MN

About The Position

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. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. The Senior Product Quality Specialist is a senior-level quality professional responsible for providing independent quality oversight of manufacturing operations and execution of quality systems. This role serves as a primary quality representative for assigned clients and project teams, leading complex quality activities including review of complex and high-risk documentation, reviewing and supporting critical investigations, supporting audits, and approving Annual Product Reviews (APRs). The Senior Specialist acts as a subject matter expert within QA Operations, ensuring compliance with cGMP requirements, company procedures, and client/regulatory expectations while supporting continuous improvement initiatives and maintaining strong client relationships.

Requirements

Bachelor’s degree
6 years of direct work experience required in a pharmaceutical/biotechnology operations or other GMP-related industry with a minimum of 2 years of experience in Quality Assurance or Quality Control.
Strong knowledge of cGMP regulations and pharmaceutical quality systems.
Strong technical writing and documentation review skills.
Excellent analytical, problem-solving, and decision-making abilities.
Ability to work independently with minimal supervision.
Strong verbal and written communication skills.
Ability to effectively manage multiple priorities in a fast-paced manufacturing environment.
Strong computer skills required.
Knowledge of the following software packages is strongly recommended: SAP Veeva Microsoft Suite (including Word, Excel, Visio, and PowerPoint)
Demonstrated experience reviewing and approving complex GMP documentation.
Broad knowledge of quality systems and experience leading investigations and performing quality risk assessments.
Experience supporting client, regulatory, and internal audits.

Nice To Haves

ASQ certification such as CQIA, CQA, or CQE

Responsibilities

Review and approve complex and major-risk GMP documents, including SOPs, validation protocols/reports, change controls, and technical reports.
Author, support, review and approve major-risk investigations, including deviations, CAPAs, complaints, laboratory investigations, and effectiveness evaluations to ensure quality, compliance, and appropriate root cause determination.
Conduct risk assessments and recommend appropriate corrective and preventive actions.
Evaluate quality events and documentation for regulatory compliance, product quality impact, and patient safety considerations.
Independently represent Quality Assurance on cross-functional project teams and provide quality leadership for assigned products and programs.
Serve as the primary Quality contact for assigned clients and maintain strong client relationships.
Provide quality guidance and risk-based decision-making support to Manufacturing, Quality Control, Engineering, Validation, and other functional groups.
Support internal, customer, and regulatory audits by serving as a Quality subject matter expert and audit scribe.
Review and approve Annual Product Reviews (APRs) and assess quality trends, product performance, and process capability.
Provide Quality oversight for material/equipment activations and other SAP product related activities, ensuring compliance with applicable procedures and regulatory requirements.
Support continuous improvement initiatives that strengthen quality systems, operational efficiency, and regulatory compliance.
Mentor and provide technical guidance to junior-level QA personnel.
Ensure compliance with applicable cGMP regulations, company procedures, and client quality requirements.
Function as a subject matter expert within QA Operations by independently making quality decisions within established procedures and quality systems and influencing quality outcomes through collaboration and expertise.
Ability to effectively manage multiple priorities in a fast-paced manufacturing environment.
Perform junior QA tasks, including batch record review, document control, and other responsibilities as assigned to support business operations.