Deviation Investigation Lead

Job Description

Job Summary: Responsible for leading and conducting deviation investigations on a pharmaceutical manufacturing floor, identifying root causes, and implementing corrective and preventive actions (CAPAs).

Job Requirements:

• Extensive experience on a pharmaceutical manufacturing floor.
• Strong understanding of root cause analysis and CAPA implementation.
• Proficient in technical writing, particularly in generating deviation reports.
• Familiarity with risk evaluation tools and conducting risk assessments.
• Prior experience in a lead role for deviation investigations.

Preferred

Skills:

• In-depth knowledge of regulatory guidelines and compliance in pharmaceutical manufacturing.
• Experience in collaborating with cross-functional teams, including production, quality control, and regulatory affairs.
• Ability to assess the impact of deviations on product quality and safety.

Job Responsibilities:

• Lead deviation investigations to identify root causes and implement effective CAPAs.
• Ensure timely initiation, documentation, and closure of deviation investigations.
• Review and assess the impact of deviations on product quality, safety, and regulatory compliance.
• Generate and communicate deviation reports to relevant stakeholders.
• Participate in risk assessments and recommend mitigation strategies.
• Collaborate with manufacturing and quality teams to track and address deviations.
• Stay updated with industry regulations, guidelines, and best practices related to deviations in pharmaceutical manufacturing.

Pay Details: $70.00 to $75.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.