Quality Assurance Inspector
Quality Assurance Inspector
Job Number: 20-05100
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance Inspector for our client in Carlisle, PA.
Eclaro’s client is among the world’s largest pharmaceutical companies, trusted by billions to provide superior, cutting-edge, and inexpensive medicine that improves health and well-being. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- The position will provide investigation and technical support for all equipment, unit operations and processes on site.
- Main functions include timely investigation and root cause analysis for manufacturing incidences, event reports, deviations and other technical support for the production processes.
- Assists in the formation and implementation of Corrective and Preventative Actions (CAPAs) to prevent reoccurrence.
- Leads cross-functional investigation teams.
- Responsible for reporting key investigation metrics.
- Proficient in the production operations and quality procedures for the area(s) to facilitate compliance to regulations and to provide a good understanding of processes when conducting cGMP investigations.
- Initiates, writes, reviews, edits, and drives investigations, interim reports, and commitments to closure to meet established timelines using the Trackwise/QTS system.
- Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors during manufacturing and packaging operations.
- Participates in understanding failures (FMEA) and resulting CAPAs through investigations, root cause analysis, and incident reports.
- Maintains proficiency in performance of all applicable Standard Operating Procedures (SOPs).
- Authors and reviews SOPs, master batch records and other site technical documents.
- Other duties, responsibilities and qualifications may be required and/or assigned as necessary.
- Bachelor's degree in a technical field (Biology, Chemistry, Engineering, or Pharmacy)
- 4-6 years experience overall
- 1-2 years experience in conducting and documenting manufacturing incident or other types of investigations is required.
- Training in Root Cause Analysis (method 1), CAPA, Human Performance (Client), and Technical Writing programs.
- Familiarity with the use and functionality of Trackwise/QTS or similar enterprise system highly preferred.
- Experience in a manufacturing environment.
- Strong verbal communication skills.
- Demonstrated advanced technical writing skills.
- Strong understanding of cGMP concepts and requirements.
- Strong understanding of mathematics and statistics.
- Able to demonstrate accuracy and thoroughness while completing work in a timely manner.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Chris Sta Juana
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.