Manufacturing Compliance Specialist

Description

• Review and assist in record closure for Lot Disposition process.
• Perform root cause analysis on manufacturing deviations and create deviation reports.
• Lead investigations for manufacturing issues and bring them to resolution with minimal supervision.
• Work closely with manufacturing operations and QA team to drive CAPAs to timely closure.
• Update and revise site manufacturing SOPs.
• Maintain facility GMP compliance and assist in ensuring regulatory inspection readiness.
• Initiate corrective and preventative actions (CAPA) to prevent recurrence of deviations.
• Operate within site quality and asset management systems.
• Collaborate with team members to ensure project progression and represent the Manufacturing department’s interests on multidisciplinary project teams.
• Serve as a liaison between manufacturing, quality, and process development teams.
• Support quality system programs such as Deviation, CAPA, and Change Management.

Requirements

• Experience using GMP compliance in clinical/commercial manufacturing environments.
• Experience using quality management software such as MasterControl, Trackwise preferred.
• Strong technical writing skills.
• Strong knowledge of FDA and EU regulations for APIs and Drug Products.
• Communicate compliance strategy and rationale clearly, both verbally and in writing.
• Minimum of 5+ years of experience conducting investigations and root cause analysis in a pharmaceutical or FDA/GMP environment.
• Ability to understand and apply GMP regulations related to manufacturing.
• Equivalent education and experience may substitute for stated requirements.
• B.S. in Chemistry, Biochemistry, Biology, or related scientific discipline preferred.
• Experience with asset management software like Blue Mountain preferred.

Benefits

• Health Spending Account (HSA)
• Employee Assistance Program
• Transportation benefits
• Critical Illness, Accident, and Hospital
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Short and long-term disability
• Medical, dental & vision
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

Training + Development

Interview process

Visa Sponsorship

Security clearance