Overview
MQA Specialist/2nd Shift Jobs in Cary, North Carolina, USA at Indivior
Position: MQA Specialist (2nd Shift)
TITLE:
MQA Specialist (2nd Shift)
Reports To: MQA Manager
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.
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.
POSITION SUMMARY:
The Manufacturing Quality Assurance (MQA) Specialist is responsible for providing quality oversight to all manufacturing areas to ensure product quality and SOP/GMP compliance. The MQA Specialist will work closely with production personnel to complete in-process batch record review, resolve batch related issues, and ensure proper good documentation practices.
ESSENTIAL FUNCTIONS:
Required to be on-the-floor and present to provide quality oversight for all critical manufacturing processes. Ability to make independent decisions regarding quality related concerns or issues.
Address daily quality concerns and questions related to operating and environmental issues.
Clearly communicate complex issues to Management personnel.
Work closely with production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling.
Complete gown qualification and maintain status for entry into Aseptic processing area.
Perform aseptic gown training and certification sampling.
Identify deviations and ensure the deviations are initiated by the appropriate personnel.
Perform AQL checks on product when necessary and maintain AQL qualification status.
Conduct viable and nonviable environmental monitoring throughout facility, including aseptic processing areas and classified manufacturing areas.
Collect facility waters and submit for testing.
Requisition of materials, maintaining inventory, and receive and store prepared media.
Enumerate bacteria and report excursions, if required.
Perform additional duties and responsibilities as assigned.
Ensure processes and products are in compliance with all local, state, and federal rules and regulations.
MINIMUM QUALIFICATIONS:
Bachelor’s degree in science, engineering field, or equivalent experience.
1-3 years experience in the pharmaceutical industry (cGMP environment) and aseptic technique.
Ability to get gown certified within 30 days.
Physical requirements include standing and walking up to 8 hours, lifting or moving up to 35 pounds.
Good communication (oral, written) and interpersonal skills are necessary.
An acceptable visual acuity test is required for this position.
COMPETENCIES/CONDUCT:
Embrace Indivior core culture principles.
Embrace the dynamics of team support, team collaboration and team success.
Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives.
Celebrate and embrace diversity, equity and inclusion.
BENEFITS:
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.
Comprehensive Medical, Dental, Vision, Life and Disability coverage.
Tuition reimbursement.
Concierge/personal assistance services.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled
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Title: MQA Specialist/2nd Shift
Company: Indivior
Location: Cary, North Carolina, USA
Category: Healthcare, Quality Assurance – QA/QC
