Quality Manager

4 weeks ago

King Of Prussia, United States Ecolab Full time

Ecolab has an exciting new opportunity for a Quality Manager to join our Life Sciences manufacturing facility in King of Prussia, PA. This is a great opportunity to join and advance with an innovative and high-growth global company committed to sustainability.The Quality Manager will oversee the quality control and quality system functions, ensuring compliance with global pharmaceutical regulations and standards, Ecolab and Purolite quality policies, and industrial standards such as ISO 9001.What's in it For You:
The opportunity to take on some of the world's most meaningful challenges, helping customers achieve clean water, safe food, abundant energy and healthy environments
The ability to make an impact and shape your career with a company that is passionate about growth
The support of an organization that believes it is vital to include and engage diverse people, perspectives and ideas to achieve our best

Main Responsibilities - Quality Control:
Responsible for all quality control laboratory supervisors, leads, and technicians.
Is accountable for all incoming, in-progress and final product testing.
Monitors and communicates non-conformances to department supervisors and senior managers.
Ensures adequate staffing and resourcing for all functions within the department.
Recommends measures to improve methods, quality of product.
Recommends and implements changes in working conditions and use of equipment to increase efficiency of the department.
Assists company representatives in quality matters Supervises and maintains all lab instrumentation - including PM and calibration schedules.
Prepares and distributes precise and timely reports as required.
Oversees maintenance of all quality control records and samples.
Interprets company policies to department workers and enforces safety regulations.

Main Responsibilities - Quality Systems:
Management Representative for manufacturing site Quality Management System (QMS).
Communicates all deviations and non-conformances to plant management and senior leadership as needed.
Works closely with global quality team.
Establishes and oversees internal audit process to ensure site is maintained in an audit ready state.
Communicates with authorities and customers and coordinates the planning and management of audits.
Analyzes and approves general and operating procedures, work instructions and other quality-related documents.
Develops and maintains site quality metrics and ensures compliance and identification of trends leading to site/process/product improvements.
Reviews and approves validation protocols and reports.
Ensures that quality-related complaints are investigated and resolved as required.
Oversees process for reviews of completed batch production and laboratory control records of critical process steps before release of the products for distribution.
Releases or rejects all products. Releases or rejects intermediates for use outside the control of the manufacturing company. Establishes a system to release or reject raw materials, intermediates, packaging, and labeling materials.
Ensures a robust stability program supporting product, raw materials, QC Reagents and sets retest/expiry dates and storage conditions where appropriate.
Ensures adherence to professional standards and ethics.
Provides ad-hoc reports for senior management as required.
Performs other duties as assigned.

Basic Qualifications:
Bachelor of Science in Chemistry, Chemical Engineering, Biology, or another relevant scientific field
7 years Quality (QA and/or QC) experience
3 years of supervisory or management experience
3 years' experience in Quality Systems Management
Knowledge of quality assurance requirements for pharmaceuticals: 21 CFR Parts 210/211, ISO 9001 standard requirements
Knowledge of ISO 19011 standard (the principles of auditing, managing an audit program and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process)

Preferred Qualifications
Product development and project management experience
Hands-on analytical laboratory experience
Experience with performing and hosting audits from regulators and customers
Proven analytical, evaluative, and root cause analysis abilities

#onsiteBenefits Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families. Click here to see our benefits. If you are viewing this posting on a site other than our Ecolab Career website, view our benefits at jobs.ecolab.com/working-here. Potential Customer Requirements NoticeTo meet customer requirements and comply with local or state regulations, applicants for certain customer-facing roles may need to:
Undergo additional background screens and/or drug/alcohol testing for customer credentialing.
Be fully vaccinated for COVID-19, including a booster if eligible, unless a religious or medical accommodation is requested by the applicant and approved by Ecolab.

Americans with Disabilities Act (ADA) Ecolab will provide reasonable accommodation (such as a qualified sign language interpreter or other personal assistance) with our application process upon request as required to comply with applicable laws. If you have a disability and require accommodation assistance in this application process, please visit the Recruiting Support link in the footer of each page of our career website.

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