Quality Assurance Auditor

Posted 16 Days Ago
Be an Early Applicant
South Bend, IN
1-3 Years Experience
Pharmaceutical
The Role
The Quality Assurance Auditor will conduct quality control checks, identify non-conforming products, conduct root cause analysis, and ensure compliance with company standards. Responsibilities include reviewing production parameters, testing samples, maintaining work area cleanliness, instrument calibration verification, and other related duties.
Summary Generated by Built In

Quality Assurance Auditor

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 for immediate addition to our fast growing team. 

Job Description:

The Quality Assurance Auditor will perform quality control checks per specifications, identify non-conforming products and perform root cause analysis.

Responsibilities:

  • Review of production line parameters and performance for adherence to Company Standard Operating Procedures, Quality Guidelines and Facility Procedures
  • Testing samples for physical adherence to Quality Specifications for Finished Product
  • Pull and identify product samples for the internal lab, retain, and external customers
  • Responsible for work area cleanliness and organization
  • Instrument Calibration Verification
  • Ability to follow detailed instructions
  • Must be flexible to work 8-10 hour days
  • Able to lift a minimum of 30 lbs
  • Ability to climb stairs/ladder
  • Ability to work in a Cleanroom environment and lab
  • Must have good communication skills, both verbal and written
  • Able to work safely, carefully and follow strict guidelines
  • Detail oriented
  • Other duties as assigned

Education and/or Experience:

  • Education: High School or higher, excellent mathematics and problems solving skills preferred
  • 2-3 + years hands-on experience with quality systems and checks
  • Microsoft (Word/Excel) skills
  • Math skills

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.

The Company
South Bend, IN
103 Employees
On-site Workplace
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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