Quality Assurance Manager

Date: Sep 19, 2023

Location: Tyrone, PA, US, 16686

Company: W. R. Grace & Co.

Requisition ID: 22339 

Built on talent, technology, and trust, Grace is a leading global supplier of catalysts and engineered materials. The company’s two industry-leading business segments—Catalysts Technologies and Materials Technologies—provide innovative products, technologies, and services that enhance the products and processes of our customers around the world. Grace employs approximately 4,300 people in over 30 countries.

Job Description

Grace is seeking a Quality Assurance Manager to join our Fine Chemical Manufacturing Services team! The Tyrone location of Grace produces a portfolio of products including specialty pharmaceutical and agricultural chemicals, refinery catalysts, food grade products and performance chemicals.  Tyrone is nestled in the mountains of central Pennsylvania and is located within twenty-five minutes of Penn State University.  The position reports to the Plant Manager.

Responsibilities

  • Maintains Site Quality Management Systems and serves as the Quality System ISO 9001-2015 Management Representative.
  • Ensures that GMP expectations are met and in compliance to applicable standards.  Acts as site contact for FDA interfaces.  Ensures adherence to Food Safety, Food Defense, Kosher, and Halal expectations and standards. 
  • Responsible for management of Grace customer complaint system for site.
  • Primary interface and contact point for Grace commercial, tech service, and other resources to support and resolve customer issues.
  • Responsible for coordinating and leading all customer audits.
  • Responsible for managing the process of dispositioning and releasing all finished products from Tyrone.
  • Ensures quality management system and laboratories adhere to applicable government regulations, customer requirements, and certification requirements.
  • Drives continuous improvement via RCCA and Six Sigma techniques.
  • Ensures analytical data and services meet internal and external customer needs and expectations, which would include data review and product release.  Monitors internal and external customer satisfaction using metrics.

Required Qualifications

  • 4-year B.S. degree in Chemical Engineering, Chemistry or Life Science
  • 5+ years of relevant cGMP/GMP and/or FDA experience in a manufacturing environment
  • Good communication skills
  • Must be a capable leader, able to influence the organization from the shop floor to senior leaders.
  • Must be able to build relationships with various functional and business leaders to drive change in their areas.
  • Self-motivated with an ability to make independent and informed decisions
  • Extensive knowledge of Quality System and Product Regulatory requirements (ISO 9001:2015 / cGMP / HACCP / etc.)

Preferred Qualifications

  • Knowledge of EU, USP, ICH, FSMA, IPEC, IFAC
  • Excellent communications skills to include written and verbal communications as well as active listening.
  • Interpersonal savvy to work effectively with diverse groups of people.
  • Exhibits sound and accurate judgment skills as well as ability to make appropriate, timely decisions.
  • Ability to act decisively using fact-based approaches in problem solving.
  • Facilitation of work processes.
  • Strong critical thinking ability.
  • Leadership of focused projects.
  • Strong production mentality; results oriented, demonstrated sense of urgency when necessary.
  • Working knowledge of ISO 9001, SPC/SQC. cGMP
  • Proficient in MS Office software to include Word, Excel, and Access

Benefits

U.S. Employee Benefits Summary (grace.com) 

Medical, Dental, Vision Insurance

Life Insurance and Disability

Grace Wellness Program

Flexible Workplace

Retirement Plans 

401(k) Company Match – Dollar to dollar up to the first 6%

Paid Vacation and Holidays

Parental Leave

Tuition Reimbursement

Company Donation Match Program 

US Employee Benefits Summary at Grace.com

Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.


Nearest Major Market: Altoona
Nearest Secondary Market: Johnstown