Job Description

Quality Assurance Associate Specialist
Job Number: 21-04747
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance Associate Specialist 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!
 
Position Overview:
  • Will be the first line for operational quality advice and support for Production and other site areas
  • Will drive early detection and help prevent potential quality issues
 
Responsibilities:
  • Supports the release team by performing review of GMP documentation on executed batch records and assisting with resolution of issues in a timely manner
  • Completes real time record reviews as manufacturing records are generated and coaches or mentors individuals to build site capability
  • Provides Quality Oversight for the production areas including Manufacturing, Packaging, and Warehouse and consults on quality issues
  • Investigates and completes Consumer Complaint Investigation Reports
  • May assist or lead Quality Risk Assessments
  • May lead or support changes at the site through the Change Management Process
  • Leads/facilitates/participates/completes cross-functional team investigations utilizing root cause analysis tools
  • Assists in completion of CAPA assigned within the Quality Department
  • Participates in GMP audits and provides product knowledge and support for regulatory responses
  • Works across multiple value streams to promote a quality culture and support continuous improvement
  • Maintains effective communication and partnership with Operations and Materials Management department
  • Coordinates delivery of product samples to the laboratory for shipment, storage, and testing
  • Adapts to changes in the work environment and must be able to change shifts or work overtime and/or weekends as needed
  • Other duties, responsibilities and qualifications may be required and/or assigned as necessary
 
Qualifications:
  • Bachelor's degree in a scientific discipline from an accredited college or university
  • Associate Degree and a minimum of 2 years of cGMP experience, or a high school diploma with 4 years of cGMP experience in a manufacturing environment may be considered
  • Ability to demonstrate accuracy and thoroughness while completing work in a timely manner
  • Strong attention to detail and organizational skills
  • Knowledge of Technical Writing techniques
  • Effective interpersonal and communication skills
  • Follows instructions, policies, and procedures
  • Minimum 1 year of cGMP experience
 
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:
June Binuya
junethel.binuya@eclaro.com
2128047476
June Binuya | LinkedIn
 
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.

Application Instructions

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