Production Supervisor - 2nd Shift

Indivior•Raleigh, NC

About The Position

The Production Supervisor is responsible for the safety, quality, and performance of the prep, compounding, filling, and inspection areas, working in both aseptic and non-aseptic environments. The role plans and coordinates all aspects of the production area and oversees day-to-day operations, cGMP compliance, batch documentation, continuous improvement, and team development. The supervisor also supports investigations, audits, SOP updates, and cross-functional efforts to address production issues and improve performance.

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 math 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 maintain unquestionable ethics and integrity and stand firm on those principles under pressure.
Know and adhere to policies applicable to the role and function, and speak up 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 cGMP compliance in operational areas and establish systems that support 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.
Drive continued improvement in operational areas.
Trend KPIs and take appropriate actions.
Develop and manage people.
Become certified on operational-area curriculums to understand and improve processes and provide coverage for breaks and vacancies.
Lead cross-functional teams to resolve urgent production issues and implement improvements.
Work independently with the operational team to improve KPIs and address trends and tasks.
Investigate pharmaceutical operations and facility nonconformances, identify deviations from standards, determine probable root causes, and identify solutions to improve manufacturing processes, SOPs, and supply-chain business practices.
Review supporting documentation, including batch and ancillary documentation, test results and CoAs, product specifications, training records, SOPs, calibration records, packaging documents, and validation protocols.
Assist with deviation and CAPA investigations, and be able to take over and finalize an investigation or CAPA if needed.
Assist with SOP revisions as a subject-matter expert in the operating area.
Serve as the subject-matter expert during internal and external audits, lead presentations, and present to auditors.
Lead Tier 1 meetings and participate in Tier 2 meetings.
Build a self-sufficient team that can work independently with minimal oversight.
Cover for peers and the manager when needed.

Benefits

Eligible to participate in the company 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.
Comprehensive 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 coverage.
Wellness programs, discounts, and other perks.