TITLE : Production Investigator / Technical Writer
Reports To : Sr. Manager Production
Location : Raleigh
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.
POSITION SUMMARY :
The Production Investigator role is responsible for investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned.
ESSENTIAL FUNCTIONS :
The responsibilities of this role include, but are not limited to, the following :
- Interact with multiple functional groups to understand the problem, identify root cause(s), and assist in identifying appropriate corrective and / or preventive actions to prevent reoccurrence.
- Assist Operations and Quality Assurance teams to determine the disposition of non-conforming in-process product and determine if a field alert or recall is required for product that has been released.
MINIMUM QUALIFICATIONS :
Associate degree is required; Bachelor of Science degree preferred.2+ years of experience in Pharmaceutical, Medical Device or Biotech environment writing standard operating procedures, protocols and / or reports.Aseptic and injectable manufacturing experience is a plus.Good communication (oral, written) and interpersonal skills are necessary.COMPETENCIES / CONDUCT :
Independently investigate pharmaceutical operations and facility nonconformances, identifying any deviations from standards.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 in support of the investigation.Collaborate with process SMEs, technical, and production personnel to understand events and occurrences.Independently write complex technical reports, describing investigation results and complete according to standard reporting and completion timelines.Assist with revision to SOPs pertaining to component preparation, compounding, filling, and stoppering of sterile vials based on investigation findings.Obtain and maintain aseptic gowning qualification.BENEFITS :
3 weeks’ vacation plus floating holidays and sick leave401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributionsU.S. Employee Stock Purchase Plan- 15% DiscountComprehensive Medical, Dental, Vision, Life and Disability coverageHealth, Dependent Care and Limited Purpose Flex Spending and HSA optionsAdoption assistanceTuition reimbursementConcierge / personal assistance servicesVoluntary benefits including Legal, Pet Insurance and Critical Illness coverageGym, fitness facility and cell phone discountsGUIDING PRINCIPLES :
Indivior’s guiding principles are the foundation for each employee’s success and growth.
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.
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.EQUAL EMPLOYMENT OPPORTUNITY
EOE / Minorities / Females / Vet / Disabled
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