What are the responsibilities and job description for the Quality Assurance Specialist position at SoTalent?
Quality Assurance Specialist II
About the Role:
This position provides Quality Assurance (QA) support for manufacturing processes and critical utilities, ensuring compliance with regulatory requirements and industry best practices. The role involves identifying and assessing quality risks, supporting manufacturing through Electronic Batch Management (EBM), and guiding other team members.
The Quality Assurance Specialist II will handle multiple projects, demonstrate problem-solving and leadership skills, and contribute to continuous quality improvement.
Key Responsibilities:
- Provide ongoing Quality Assurance support for manufacturing processes and critical utilities.
- Conduct internal assessments and evaluations, collaborating with production supervisors, engineering, and internal teams.
- Collect and analyze accurate, objective evidence regarding risks and compliance.
- Review electronic batch records, identify nonconformances, and participate in investigation and Corrective and Preventive Action (CAPA) activities.
- Provide training and coaching to employees on quality and compliance-related topics.
- Write, review, and revise Standard Operating Procedures (SOPs) to align with regulatory and company requirements.
- Oversee review and audit of reports, including protocols, qualifications, and regulatory submissions.
- Participate in multi-site QA projects as a contributor, coordinator, or lead.
- Work closely with Manufacturing, Compliance, Quality Control (QC) Laboratories, and Technical Services to ensure product safety and quality.
- Apply critical thinking skills to make quality decisions based on regulatory knowledge and industry trends.
Qualifications & Experience:
- Bachelor’s degree in Science or Business preferred. In lieu of a degree, 3 years of experience in Quality Assurance within a pharmaceutical, medical device, or similarly regulated industry.
- Strong problem-solving, verbal, and written communication skills.
- Experience with TrackWise, Delta V, and Electronic Batch Record Management preferred.
- Detail-oriented with the ability to multitask and manage multiple projects.
- Strong interpersonal, influencing, and negotiation skills.
- Experience in metrics tracking and team performance management.
- Knowledge of Electronic Quality Systems, Process Control Systems (BAS, PLC), and FDA regulations.
- Understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Proficiency in Microsoft Word, Excel, and PowerPoint.
Shift & Compensation Details:
- Weekend Days: Friday – Sunday, 6:00 AM – 6:30 PM ( 5% Weekend Shift Differential).
- Rotating Monday: Every other Monday, 8-hour shift (hours vary).
- Base Salary: Competitive, based on experience and qualifications.
