Quality Assurance Specialist II/III

Seran is seeking a Quality Assurance Specialist to support the daily activities of Serán’s Quality Assurance department supporting GMP clinical manufacturing operations. This individual will be responsible for reviewing and approving raw material records, production records, investigations/CAPA, and change control. Additional responsibilities include manufacturing floor support and continuous improvement of quality processes.

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.

Requirements

• 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.
• 3+ years GMP manufacturing or QA experience.
• Prolonged periods of sitting or standing at a desk and working on a computer.

Preferred

• Bachelor’s degree in a scientific discipline preferred.

• Must be able to lift up to 15 pounds at times.
• Adheres to consistent and predictable in-person attendance.