The posting
TITLE:
Production Supervisor - 2nd Shift
WHO WE ARE
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.
POSITION OVERVIEW
The Production Supervisor role is responsible for safety, quality and performance of the prep, compounding filling area and inspection area. Will be working in an aseptic and non-aseptic area. The role will plan and coordinate all aspects of the production area.
HOW YOU’LL MAKE AN IMPACT
The responsibilities of this role include, but are not limited to, the following:
- Oversee that operational areas are in cGMP compliance, and responsible for establishing systems that support the continuous improvement of procedures 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 continued improvement in operational areas.
- Trend and take appropriate actions to agreed KPI.
- People development and management.
WHAT YOU’LL BRING
- Demonstrated leadership and supervisory skills
- Minimum five (5) years of experience in a regulated industry
- Minimum three (3) years related experience supervision is preferred
- Experience in cGMP manufacturing or clean room production environment is preferred
- Pre-filled syringe experience preferred
- 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 ability to solve problems in a fast-paced environment
- Get certified on all the curriculums in the operational area to 1, understand the process and help to improve it. 2. Help to cover breaks, vacancies etc
- Lead cross functional teams to solve urgent production issues, implement improvements
- Work with operational team to improve KPIs or other trends/tasks 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 presentations and present to the auditing team
- Lead Tier 1 meeting and participate in Tier 2 meeting
- Build a self-sufficient team that can work independently and have very little overview
- Cover for peers and manager if needed
HOW WE INVEST IN OUR PEOPLE
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:
Pursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company. The following benefits are provided by Indivior, subject to eligibility requirements.
Starting Salary: $100,000-$115,000 USD
*Note actual salary is based on qualifications and experience
- 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
- Competitive PTO plus company closure from December 24th- January 1st
- 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
OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT
Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behavior.
Employee Obligations:
- Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
- Risk IQ: Know what policies apply to your role and function and adhere to them.
- Speak Up: If you see something, say something.
Manager Obligations:
- Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
- Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
- Model and reinforce a Speak Up culture on your team.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled are encouraged to apply!
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.
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