What are the responsibilities and job description for the Quality Assurance Supervisor position at ECOLAB?
The Quality Assurance Supervisor will perform quality assurance functions supporting the new King of Prussia, Pa manufacturing facility with specific areas of focus including change control, regulatory compliance, records retention, and document control. The QA Supervisor will follow quality control guidelines and procedures to ensure that raw materials and finished goods comply with engineering and product specifications. Will lead and coach technicians in conducting quality assurance tests to ensure products meet established specifications.
What You Will Do:
- Training in systems/process and auditing/oversight to ensure alignment with API (Active Pharmaceutical Ingredient) GMP regulations, ISO 9001, and customer requirements.
- Acts as a Regulatory Compliance reviewer to ensure changes potentially impacting registered details (e.g. DMF's) are fully assessed through their proposal, execution, and implementation in alignment with the Regulatory Affairs function, customers, and regulators.
- Ensures completeness of documentation and applies A.L.C.O.A. (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.
- Generates and tracks customer communications related to changes, works with commercial and regulatory teams to ensure proper communication.
- Understands regulatory dossier change processes.
- Assist with Quality Management System (QMS) training.
- Quality System oversight, metrics and improvements including vendor monitoring, change controls, CAPA, escalation and risk management.
Qualifications:
- Bachelors degree in science such as Chemistry, Biochemistry, Chemical Engineering, or related scientific field.
- 5 years' experience in Pharmaceuticals/GMP supporting quality (QA/QC) manufacturing.
- Experience with ISO 9001 or ISO 13485 Quality Management Systems.
- Clean room gowning experience required.
- Experience with ETQ, Trackwise, Veeva, SAP, Open Lab or ChemStation.
Benefits
Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families. 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.
Covid-19 Vaccine Notice
Due to local mandates and customer requirements, applicants for certain customer-facing positions must be fully vaccinated (which in some situations requires 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.
Our Commitment to Diversity and Inclusion
At Ecolab, we believe the best teams are diverse and inclusive, and we are on a journey to create a workplace where every associate can grow and achieve their best. We are committed to fair and equal treatment of associates and applicants. We recruit, hire, promote, transfer and provide opportunities for advancement on the basis of individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, we will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, disability, or status as a covered veteran.
In addition, we are committed to furthering the principles of Equal Employment Opportunity (EEO) through Affirmative Action (AA). Our goal is to fully utilize minority, female, disabled and covered veteran individuals at all levels of the workforce. Ecolab is a place where you can grow your career, own your future and impact what matters.
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance and the San Francisco Fair Chance Ordinance.
