Supervisor, Production

Indivior • Raleigh, NC

23d • Onsite

About The Position

The supervisor, production role is responsible for safety, quality and performance of the prep, compounding and filling area.

Requirements

• Demonstrated leadership and supervisory skills.
• Minimum five (5 ) years of experience in a regulated industry.
• Ability to apply analytical reasoning and root cause analysis to solve problems.
• Strong math and calculating skills.
• Computer skills.
• Ability to read, understand, interpret and implement technical writing and instruction as well as have exceptional abilities to problem solve in a fast-paced environment.

Nice To Haves

• Minimum three (3) years related experience supervision is preferred.
• Experience in cGMP manufacturing or clean room production environment is preferred.

Responsibilities

• Oversee that operational areas are in cGMP compliance, and responsible for establishing systems that support the continuous improvement of procedures in order to heighten quality.
• Ensures the timely and accurate documentation and closeout of batch records.
• Manage the day-to-day activities of the operational area.
• Develop and review SOPs pertaining to Prep, Compounding and Filling.
• Drive the continues improvement in operational area.
• Trend and take appropriate actions to agreed KPI.
• Get certified on all the curriculums in the operational area to 1, understand the process and help to improve it.
• Help to cover over breaks, vacancies etc.
• Lead cross functional teams to solve urgent production issues, implement improvements.
• Work with operational team to improve KPIs or other trend/task independently.
• Independently investigate pharmaceutical operations and facility nonconformances, identifying any deviations from standards. This includes clearly defining problems, collecting, and organizing existing data, comparing causes to facts, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, standard operations procedures (SOPs) and supply chain business practices.
• Review supporting documentation including batch documentation, ancillary documentation, test results / CoAs, product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents.
• Assist with deviation/CAPA investigation and understand the process so if needed be able to take over and finalize an investigation/CAPA.
• Assist with revision to SOPs pertaining as an SME in the operating area.
• Be the SME during internal/external audits, lead presentation and present to the auditing team.
• Lead Tier 1 meeting and participate in Tier 2 meeting.
• Build a self-sufficient team that can work independent and have very little overview.
• Cover for peer and manager if needed.

Benefits

• Competitive PTO plus company closure from December 24th- January 1st
• Eligible to participate in Indivior’s bonus program, based on company and individual performance
• Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan
• 401(k) and Profit-Sharing Plan- Company match
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Wellness programs as well as other discounts and perks

What This Job Offers

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