What are the responsibilities and job description for the Inspection Supervisor position at Indivior?
TITLE:
Inspection Supervisor
Title: Inspection Supervisor
Reports To: Associate Director, Production
Location: Raleigh, NC
Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.
Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time. Our purpose is to bring science-based, life-transforming treatments to patients. We strive to help eliminate the stigma of addiction. We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.
We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation. We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.
Connect with Indivior on LinkedIn by visiting
www.linkedin.com/company/indivior
.
POSITION SUMMARY:
The Inspection Supervisor is responsible for safety, quality and performance of the inspection team and area.
ESSENTIAL FUNCTIONS:
The responsibilities of this role include, but are not limited to, the following:
- Oversee that inspection area is CGMP compliant and establish systems that support the continuous improvement of procedures in order to heighten quality.
- Ensure the timely and accurate documentation and closeout of batch records.
- Manage the day-to-day activities of the inspection area.
- Develop and review SOPs pertaining to Inspection.
- Drive the continues improvement in the inspection area.
- Trend and take appropriate actions to agreed KPI.
- Lead cross functional teams to solve urgent production issues, implement improvements.
- 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.
- 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.
- Lead Tier 1 meeting and participate in Tier 2 meeting.
- 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.
MINIMUM QUALIFICATIONS:
- Demonstrate leadership and supervisory skills.
- 3-5 years related experience supervision is preferred.
- Experience in cGMP manufacturing or clean room production environment is preferred.
- Ability to apply analytical reasoning and root cause analysis to solve problems.
- Strong math and calculating skills.
- Excellent computer skill
- 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.
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:
- Ability to get certified on all the curriculums in the insoection area to (1) understand the process and help to improve it and (2) help to cover over breaks, vacancies etc.
- Desire to work with operational team to improve KPIs or other trends/tasks independently.
- Ability to be an SME during internal/external audits, lead presentation and present to the auditing team.
- Capacity to build a self-sufficient team that can work independent and have very little overview.
- Ability to cover for peer and manager if needed.
BENEFITS:
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:
- 3 weeks’ vacation plus floating holidays and sick leave
- 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
- 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
- Gym, fitness facility and cell phone discounts
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
COMPLIANCE OBLIGATIONS:
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 behaviour. As part of your responsibilities, you are expected to:
Employee Obligations:
- Always act with honesty and integrity.
- 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:
- Always act with honesty and integrity
- 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.
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.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled
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