Quality Assurance Specialist Position Available In Haywood, North Carolina

Quality Assurance Specialist 4.5 4.5 out of 5 stars Hazelwood, NC 28738

Job Title :

Quality Assurance Specialist Location :

Hazlewood, MO (Hybrid)

Employment Type:

Contract Reports To:

Quality Operations Manager Job Summary:

We are seeking a Quality Assurance Specialist to support externally manufactured pharmaceutical and biopharmaceutical products. This role plays a critical function in reviewing and managing quality systems documentation, coordinating with Contract Manufacturing Organizations (CMOs), and ensuring compliance with cGMP and internal standards. The ideal candidate will bring extensive knowledge of pharmaceutical quality systems, strong communication skills, and a high level of attention to detail.

Essential Responsibilities:

Quality Support:

Review and evaluate stability reports and associated data. Review and approve CMO documentation related to batch production. Conduct detailed batch record reviews, identify discrepancies, and escalate issues to management as needed. Input and route Quality Agreements; ensure timely completion. Manage quality records including deviations, change controls, and CAPAs. Monitor and support cold-chain transportation processes and qualification. Contribute to Annual Product Quality Review (APQR) assessments and documentation. Author and revise quality systems documentation. Work within MasterControl for document authoring, routing, review, and approval processes.

CMO Governance:

Maintain regular communication (email/phone) with internal stakeholders and CMO counterparts to ensure timely production and resolution of quality-related issues.

Quality/QMS Projects:

Provide support for continuous improvement initiatives across quality and compliance processes.

Qualifications:

Education:

Bachelor//’s Degree in a scientific discipline is required.

Experience :

Minimum 5 years of progressive experience in pharmaceutical Quality Assurance roles. Experience working directly with Quality Systems including deviations, CAPAs, change control, training, and document management. Knowledge of current Good Manufacturing Practices (cGMP), especially 21 CFR Parts 210/211.

Preferred:

Experience in sterile injectable pharmaceuticals.

Key Competencies:

Strong organizational skills and the ability to manage multiple priorities. Works independently with minimal supervision. Proficient in Microsoft Office Suite. Experience with MasterControl (highly preferred). Excellent verbal and written communication skills. Collaborative and proactive team player. Diligent, thorough, and demonstrates a high level of attention to detail. A high degree of accountability and ownership in work tasks.