GMP Quality Assurance Specialist (Hybrid)

Actalent; United States; Hybrid; USD 36,000 - 39,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

PTO / Vacation

Transit benefits

Employee Assistance Program

Job summary

Actalent is seeking a Quality Management / QA Specialist to process quality records within a QMS, supporting site procedures and ensuring timely workflow steps in the electronic system.

The role requires deviations/CAPAs/change controls experience, GDP documentation, and collaboration across departments while upholding SOPs and cGMP standards. This is a contract, hybrid Columbus-based position with potential extension.

Qualifications

• Bachelor's degree in Science required or preferred.
• At least 1 year of experience in GMP.
• Experience following SOPs, FDA, or GMP protocols.
• Experience with QMS software, ideally Veeva.
• Strong communication skills and ability to work cross-functionally.

Responsibilities

• Support administrative functions for deviations, CAPAs, change controls, continuous improvements, and effectiveness checks within Veeva to maintain and organize the site's in-process quality records.
• Communicate effectively between departments to ensure all operations have the required inspected materials.
• Accurately document results, observations, and procedures following GDP.
• Escalate any non-conformance or deviations for investigation and resolution.
• Adhere to SOPs, cGMP guidelines, and regulatory requirements.

Skills

GMP experience

QMS software

Cross-functional communication

Strong documentation

Education

Bachelor's degree in Science

Tools

Veeva

Job description

Actalent is seeking a Quality Management / QA Specialist to process quality records within a QMS, supporting site procedures and ensuring timely workflow steps in the electronic system.

The role requires deviations/CAPAs/change controls experience, GDP documentation, and collaboration across departments while upholding SOPs and cGMP standards. This is a contract, hybrid Columbus-based position with potential extension.