Production Supervisor - 2nd Shift

Indivior • Raleigh, NC

13d • $100,000 - $115,000

About The Position

The Production Supervisor is responsible for the safety, quality, and performance of the prep, compounding, filling, and inspection areas. The role works in both aseptic and non-aseptic environments and plans and coordinates all aspects of the production area.

The supervisor oversees cGMP compliance, timely and accurate batch-record documentation and closeout, and day-to-day operational activities. The role develops and reviews SOPs, drives continuous improvement, monitors KPIs, and develops and manages people. It also leads and supports investigations, audits, cross-functional problem solving, and operational meetings while building a self-sufficient team.

Requirements

• Demonstrated leadership and supervisory skills.
• At least five years of experience in a regulated industry.
• Ability to apply analytical reasoning and root-cause analysis to solve problems.
• Strong mathematics and calculation skills.
• Computer skills.
• Ability to read, understand, interpret, and implement technical writing and instructions.
• Exceptional problem-solving ability in a fast-paced environment.
• Ability to investigate nonconformances and review technical and manufacturing documentation.
• Unquestionable ethics and integrity, including willingness to uphold these principles under significant pressure.
• Know and follow policies applicable to the role and function; raise concerns about potential violations or unethical behavior.

Nice To Haves

• At least three years of related supervisory experience.
• Experience in cGMP manufacturing or a clean-room production environment.
• Pre-filled syringe experience.

Responsibilities

• Oversee operational areas to ensure cGMP compliance and establish systems for continuous improvement and quality.
• Ensure timely and accurate documentation and closeout of batch records.
• Manage day-to-day activities of the operational area.
• Develop and review SOPs for Prep, Compounding, and Filling, including revisions as an operating-area subject matter expert.
• Drive continuous improvement in operational areas.
• Trend KPIs and take appropriate actions to meet agreed targets.
• Develop and manage employees, including building a self-sufficient team that can work independently.
• Complete certification in all operational-area curriculums to understand and improve processes and help cover breaks and vacancies.
• Lead cross-functional teams to resolve urgent production issues and implement improvements.
• Work with the operational team to improve KPIs and independently address trends and tasks.
• Independently investigate pharmaceutical operations and facility nonconformances by defining problems, organizing data, comparing causes with facts, identifying probable root causes, conducting interviews and subject-matter-expert discussions, and determining solutions for manufacturing processes, SOPs, and supply-chain practices.
• Review supporting documentation, including batch and ancillary documentation, test results and certificates of analysis, product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents.
• Assist with deviation and CAPA investigations, understand the process, and be able to take over and finalize an investigation or CAPA when needed.
• Serve as a subject-matter expert during internal and external audits, lead presentations, and present to audit teams.
• Lead Tier 1 meetings and participate in Tier 2 meetings.
• Cover for peers and the manager when needed.

Benefits

• Eligible to participate in a bonus program based on company and individual performance.
• Eligible for a yearly grant through the Long-Term Incentive Plan.
• Competitive paid time off and company closure from December 24 through January 1.
• 401(k) and profit-sharing plan with company match.
• U.S. Employee Stock Purchase Plan with a 15% discount.
• Medical, dental, vision, life, and disability coverage.
• Health, dependent care, and limited-purpose flexible spending accounts and HSA options.
• Adoption assistance.
• Tuition reimbursement.
• Concierge and personal assistance services.
• Voluntary legal, pet insurance, and critical illness benefits.
• Wellness programs, discounts, and other perks.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed