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Sr. Specialist Quality Assurance

3 months ago

Norwood, United States Connexion Systems & Engineering, Inc. Full time
Job DescriptionJob Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Sr. Specialist Quality Assurance

  • We are really looking for people who have more quality disposition related experience, as that will be their primary role and we will need them to be able to be up and running quickly without extensive training.

In this role, you will be responsible for providing quality assurance network support for contract manufacturing and testing. You are responsible for ensuring that all batch-related activities, including receipt, review, and release of Bulk Drug Substance (BDS) and Drug Product (DP), are conducted in compliance with regulatory standards. This role is focused on executing Batch Record Release activities following Drug Product CMO Release and authorization for shipment to Third Party Distribution Network and further disposition activities. The role requires a detail-oriented individual with strong quality assurance and regulatory knowledge, capable of making critical decisions that impact product quality and patient safety.

Here’s What You’ll Do

Provide network quality assurance support across the company CMO Drug Product QA teams, with a focus on process efficiency and quality.

Perform GMP Confirmation (Release activity) for Drug Product CMO batches, including batch record review, eQMS documentation checks and SAP release steps.

Provide administration and Veeva eQMS documentation support for archival

Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Additional duties as may be assigned from time to time

Here’s What You’ll Need (Minimum Qualifications)

Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field; advanced degree preferred.

5+ years of experience in quality assurance within the pharmaceutical or biotechnology industry, specifically in batch oversight and CMO management.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

Demonstrated experience with batch release and/or disposition activities, and batch record review.

Training in Veeva Quality Management System and SAP is preferred, or similar quality document management system.

Proficiency in regulatory requirements.

Familiarity in Drug Product GMP Manufacturing

Effective communication skills, both written and verbal.

Ability to work cross-functionally and collaborate with internal and external stakeholders.

A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.