- Responsible for overall management strategy for QC staff.
- Define priorities for the QC Analytical department. Ensure alignment of QC priorities with the site priorities/strategy, also ensuring strategy deployment.
- Leader in the Audit Room for ISO Audits, FDA Audits, Supplier Audits, and other applicable regulatory or non-regulatory body audits.
- Inspect, test, or measure raw materials used in production and finished goods being produced,
- Approved or reject materials according to standards established by Quality.
- Ensures any rejected products or materials are segregated per procedure.
- Collect, organize and report on KPI metrics and identify trends that require attention.
- Executes/Reviews validation protocols and procedures for new equipment.
- Manage and work with team to resolve non-conformances and other identified issues.
- Identify and manage business risks, opportunities in the QC Lab.
- Working, training and troubleshooting experience with HPLC, GC, Alpine Jet Sieve, IR (infra red), KF (Karl Fisher), Moisture analyzer, ICP, Stability, UV/ Vis Spectrometer.
- Working knowledge of USP/EP compendial testing/requirements.
- Bachelor's degree in science such as Chemistry, Microbiology, or Biochemistry, Chemical Engineering. or related scientific degree.
- 5 years' GMP experience working in a pharmaceutical environment.
- Demonstrated experience commissioning a new QC laboratory, Method Validation, Instrument qualifications IOQ, PQ, Calibration and daily QC Lab operations.
- Experience with ETQ, Trackwise, Veeva, SAP, Open Lab or ChemStation.
- Quality System oversight, metrics and improvements including vendor monitoring, change controls, CAPA, escalation and risk management.
- Instrument qualifications IOQ, Validations, Calibration and operations.
- Experienced in change management, root cause analysis, risk assessment, OOS/OOT investigations.
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Quality Control Manager - Norristown, United States - Ecolab
Description
As a Quality Control Manager with Purolite an Ecolab Company, you will establish quality control guidelines and testing procedures. You will ensure that raw material and finished product quality and reliability are in compliance with engineering and product specifications. Will review quality control practices and procedures to ensure that quality standards are upheld.What You Will Do:
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
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.
