Production Investigator/Technical Writer

Indivior•Raleigh, NC

1d•Onsite

About The Position

The Production Investigator/Technical Writer role is responsible for investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned. The role is also responsible for creating new documents, updating or doing annual review of documents such as SOPs, Work Instructions, & batch records in the manufacturing area. Will also support surrounding organizations if needed.

Requirements

Minimum of an Associate Degree required; Bachelor of Science degree preferred
Minimum of two (2) years of experience in Pharmaceutical, Medical Device or Biotech environment writing standard operating procedures, protocols and/or reports required
Good communication (oral, written) and interpersonal skills required

Nice To Haves

Aseptic and injectable manufacturing experience a plus

Responsibilities

Interact with multiple functional groups to understand the problem & identify root cause(s)
Assist in identifying appropriate corrective and/or preventive actions to prevent reoccurrence
Create new documents
Update SOPs and work instructions
Train organization in new documentation updates
Implement CAPAs
Coordinate and keep track of manufacturing CAPAs/Deviations to make sure the departments are in compliance
Assist in audits as a representative from production, present documents and procedures.
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
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 in support of the investigation.
Collaborate with process SMEs, technical, and production personnel to understand events and occurrences.
Facilitate meetings with various groups to discuss processes, participate in Kaizen events, and apply formal RCA tools to develop an investigational path for deviations.
Present regular updates to the Associate Director, Production.
Independently write complex technical reports, describing investigation results and complete according to standard reporting and completion timelines for on time closure.
Manage multiple priorities and deadlines independently or as part of a team to meet critical deadlines and company and departmental metrics.
Conduct GMP, GDP, SOP, and awareness training as needed for deviation resolution.
Assist with revision to SOPs pertaining to component preparation, compounding, filling, and stoppering of sterile vials, lyophilizing, capping, and inspection of product based on investigation findings.
Obtain and maintain aseptic gowning qualification.

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