Quality Assurance Specialist II/III

Duties & Responsibilities • Implementation and continuous improvement of the company’s quality systems.

• Documents authorship, review, and approval of SOPs and associated documents.

• Reviews/approves master batch records

• Raw material and product review and release.

• Oversight, review, and approval of investigations, CAPA, and change controls.

• Contributes to a culture of quality ownership, compliance, and continuous improvement

• Communicates quality-related information to internal team with guidance and recommendations.

• Supports of internal audits, client audits and regulatory inspections, as needed.

• All other duties as assigned.

• Responsibilities may increase in scope to align with company initiatives.

Required Skills & Abilities • Knowledge of GMP, FDA, and EMA regulations for clinical drug manufacturing.

• Knowledge of change control procedures, CAPA program, investigation, root cause analysis, and good documentation practices.

• Demonstrated ability to collaborate and work in cross-functional teams

• Excellent verbal and written communication skills.

• Excellent interpersonal and customer service skills.

• Excellent organizational skills and attention to detail.

• Excellent time management skills with a proven ability to meet deadlines.

• Strong analytical and problem-solving skills.

• Ability to prioritize tasks.

• Proficient with Microsoft Office Suite or related software.

• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the company.

• Demonstrated ability to collaborate and work in cross-functional teams.

Education & Experience • Bachelor’s degree in a scientific discipline preferred.

• 3+ years GMP manufacturing or QA experience.

Physical Requirements • Prolonged periods of sitting or standing at a desk and working on a computer.

• Must be able to lift up to 15 pounds at times.

• Adheres to consistent and predictable in-person attendance.