Quality Assurance Auditor Lead

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South Bend, IN
In-Office
Pharmaceutical
The Role

Quality Assurance Auditor Lead

Tri-Pac, Inc. a contract development and manufacturing company (CDMO) specializing in liquid and aerosol filling for personal care and pharmaceutical marketers, is seeking an experienced Quality Assurance Auditor Lead for immediate addition to our fast growing team. 

Job Description:
The Quality Assurance Lead actively participates in quality guidance, product resolution decisions and statistical problem-solving techniques. The Quality Assurance Lead reports to the Quality Supervisor.
Responsibilities:

  • Analyzing data, measuring products, and verifying all products to ensure proper quality of appearance, packaging, and decoration.
  • Implement and monitor all procedures and processes as they relate to Quarantine, Hold, Expired, Damages, Return Goods and Recalled product.
  • Maintains Daily Down Time Log
  • Reviews daily all Manufacturing batch records required to support shift and any off-shift needs.
  • Monitors QA and QC performance on the line. Fills in when QA or QC is absent.
  • Provides on-the-job training for new employees in the Quality Department.
  • Writing deviations and investigations as required.
  • Actively involved with and mentors less experienced co-workers.
  • Able to work overtime as needed.
  • Other duties as assigned.


Education and/or Experience:

  • Requires a High School degree or equivalent.
  • 2-3 years relevant experience in Quality/manufacturing/ production processes
  • Computer proficiency and scheduling experience required; good writing skills required.
  • Familiarity with industrial automation (e.g., distributed control and PLC-based systems) Working knowledge of safety, quality systems, and GMPs is required.

Benefits

Competitive Salary/ Pay & Packages, Vacations, Insurance, 401K, Life Insurance, Disability (Long term/ Short term) and Continuous Training. Work where you are HAPPY! Tri-Pac, Inc. also recognizes the importance of continuing education and offers Education Assistance to our employees to encourage continued personal development and growth.

www.tri-pac.us

Thank you for your interest and consideration of a career with Tri-Pac, Inc.

Tri-Pac, Inc. is an Equal Employment Opportunity / Affirmative Action Employer

To Staffing & Recruitment Agencies: Our Company does not accept unsolicited CV's or applications from agencies. We are not responsible for any fees related to unsolicited CV's or applications and explicitly reserve its right to contact candidates presented in such unsolicited CV or application.

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The Company
South Bend, IN
103 Employees
Year Founded: 2009

What We Do

Tri Pac, Inc. is a turnkey contract development and manufacturing organization (CDMO) for aerosol, liquid, tubes, and suppository consumer goods, over-the-counter product and medical devices. Markets served include Personal Care, OTC, Medical Device, Feminine Hygiene, Sexual Health & Wellness, Household and Defense.

Certifications:

- ISO 13485:2016 - Med Device GMP
- WHO GMP - Pharmaceutical GMP
- UL Health Canada OTC
- UL Retailer Certification OTC
- ISO 22716:2007 - Cosmetic/ EU GMP
- ISO 9001:2015 - Quality
- ISO 14001: 2015 - Environmental
- FDA Registered Facility - Med Device
- FDA Registered Facility - OTC
- EPA Registered Facility
- TTB Alcohol Permit
- Minority Certified Business (NMSDC)
- ITAR Registered Manufacturer/ Broker
- Organic Certified (NOP/ANSI)

Services include:

> Contract Development & Manufacturing
> Aerosol | BOV | Liquid | Tube Filling
> Gels | Foams | Ointments | Suppositories
> Supply Chain & Inventory Management
> Transfer of IP, Suitability & Methods
> Regulatory Compliance
> Research and Development
> Validation & Stability
> Quality Control & Assurance
> Logistics & Fulfillment

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