As the Quality Assurance Supervisor with Ecolab, you will contribute to the success of the business by ensuring the quality of raw materials and finished products while following guidelines and procedures in a GMP environment. Key responsibilities include continuous improvement, QMS oversight, batch release process ownership, change control, deviation management, CAPA, and document control.
What You Will Do:
- Oversee the Quality Assurance (“QA”) team, including document control.
- Lead, mentor, coach and train team members while using Ecolab performance tools and resources.
- Lead kaizen events to develop, implement, improve and maintain processes, procedures, systems, and structures related to QMS, process, and product.
- Coordinate the batch record review and approval process to ensure timely release.
- Perform disposition of raw materials and finished product in SAP.
- Prepare and participate in customer, third party and regulatory audits.
- Develop, implement and maintain training materials, work instructions, standard operating procedures (“SOPs”), forms, templates, specifications, and standards.
- Review and approve records related to commissioning, qualification, and validation (“CQV”), as well as SOPs, certificates of analysis (“COAs”), and other records, ensuring ALCOA compliance.
- Investigate deviations, customer complaints, nonconformances.
- Author CAPAs, change controls, and risk assessments.
- Ensures completion of time-critical compliance tasks, such as internal auditing and mock traceability/recall.
- Act as a Regulatory Compliance reviewer—working with Regulatory Affairs—to ensure changes potentially impacting registered details (e.g., drug master files) are fully assessed.
- Collaborate with site Engineering, Validation, and external stakeholders to ensure successful CAPA implementation, process continuous improvement, CQV, and new product transfers.
- Compile and relay key performance indicators and metrics to management.
- Assist with Quality Management System (QMS) training as needed.
- Quality System oversight, metrics and improvements including vendor monitoring, change controls, CAPA, escalation and risk management.
Qualifications:
- Bachelor of science degree in Chemistry, Biochemistry, Chemical Engineering, Regulatory Affairs, Other Engineering, or a related scientific field.
- 5 years' experience in Pharmaceuticals/GMP supporting quality (QA/QC) manufacturing, preferably in a supervisory role.
- Ability to innovate, problem solve, kaizen, and implement strategies for continuous improvement, streamlining processes and implementing new ones.
- Strong understanding of GMP manufacturing principles and programs; 21 CFR 210/211, ICH Q7, ISO 9001.
- Experience authoring, reviewing, approving deviations, CAPAs, and change controls related to process and product.
- Experience authoring, reviewing, approving CQV documentation.
- Ability to manage multiple priorities in a fast-paced production environment.
- Strong attention to detail without losing sight of the bigger picture.
- Sound decision making abilities with respect to compliance and quality.
- Effective verbal and written communication, ability to work independently, the ability to coach and train team members, the ability to complete daily tasks as assigned in a timely manner.
- Experience with ETQ, Trackwise, Veeva, SAP, LIMS, Open Lab or ChemStation.
- Microsoft Office proficiency, especially Excel.
- Six sigma, CQA professional certificates are preferred.
Annual or Hourly Compensation Range
The pay range for this position is $98,600.00 - $148,000.00. Many factors are taken into consideration when determining compensation, such as experience, education, training, geography, etc. We comply with all minimum wage and overtime laws.
Benefits
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 Notice
To 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.
Our Commitment to a Culture of Inclusion & Belonging
At Ecolab, we believe the best teams are inclusive. 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 and recruit, hire, promote, transfer and provide opportunities for advancement based on 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).
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, the San Francisco Fair Chance Ordinance, and the New York City Fair Chance Act.
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