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Quality Specialist Full-time

at Aveda/Estee Lauder in Minnesota (Published at 20-09-2019)

Position Summary: Responsible for executing Quality Assurance activities in the labs to ensure required testing adheres to all regulatory and Company guidelines. Responsible for assisting with oversight for lab testing processes with ability to troubleshoot instruments & issues and provide guidance and coaching on GMP/GLP practices in the laboratory. Provide assistance and guidance for all OOS investigations with ownership for the design and administration of the investigation process. Facilitate execution of method transfers for the labs. Review lab equipment change controls and validation protocols and reports. Support projects that improve testing harmonization and workflow efficiencies in conjunction lab leadership. Develop training program and materials and monitor for compliance.

Job Description:

Compliance (10%)

  • Compile lab data and analyze trends to develop OTC finished good and product review reports in support of annual APRs
  • Facilitate and support global safety inspections with respect to the lab and any follow ups based off findings / CAPAs
  • Ensure procedures are followed by overseeing output and work practices. Accountable for enforcing compliance to good manufacturing and lab practices.
  • Execution of data integrity checks/verifications

Continuous Improvement / Strategy (15%)

  • Facilitate resolution of raw material issues in collaboration with Global Supplier Development
  • Collaboration with R&D and other EL sites on best practices to improve efficiencies and reduce waste within the Quality Labs
  • Work closely with QA Lab Director on harmonization of testing practices across the EL sites
  • Contribute subject matter expertise to initiatives such as GLP, OOS and Global Testing Harmonization
  • Partner with the Compliance team to act as a SME for Internal audits, corporate audits, FDA inspections, etc

Oversight of QC Lab Testing (30-50%)

  • Monitor and verify Quality program outputs in the lab are meeting expectations. Additionally, provide guidance with out of trend investigations and identify continuous improvement opportunities. Quality programs may include raw material qualification, standards management (for raw materials and finished product/mass) and environmental monitoring.
  • Create quality notifications (QN and Q2 QN), working with QC Lab Analyst as necessary to gather information about the event. Follow up to ensure closure of the quality notification.

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  • Engage teams outside of the lab to support OTC Complaints & Quality Inquiry investigations.
  • Provide guidance to Quality Control team in handling deviations/CAPAs, changes, incidents, and laboratory investigations
  • Facilitate execution of method transfers for the labs
  • Monitor and verify adherence to global sample retention and document archival program
  • Liaison with TSO/R&D to review product specification for new products to ensure it is in line with process capabilities and approve new product process control plan.

Equipment Program (15%)

  • Review and approval of lab equipment change controls and management of master lab equipment list
  • Provide support to lab equipment qualification (IQ/OQ/PQ) and validation activities
  • Review and approval of lab equipment qualification (IQ/OQ/PQ) and validation protocols and reports.
  • Oversight of lab equipment administration, including calibration, preventive maintenance, and troubleshooting as needed.
  • Monitor critical control parameters (CCPs), storage chambers, process water and environment

Training (10%)

  • Oversight of lab training program
  • Identify training needs in the labs and provide/coordinate compliance, safety, hygiene and other training (internal and/or external), as needed
  • Develop, implement and train on processes and tools that support safe laboratory practices and compliance with GMP/GLP requirements

Additional Duties (10-20%)

  • Act as back-up Microbiologist as needed, especially in the event of an investigation
  • Special project work as assigned

Minimum Education Level: 4 year degree or equivalent experience
Minimum Years of Experience: 4

Addition Job Specifications:

  • Extensive experience in a microbiology is required.
  • Microbiology, analytical chemistry or product evaluation laboratory for a global consumer goods or pharma company
  • Knowledge of the scientific principles and practices in biology and chemistry.
  • Ability to interpret and assess lab compliance against GMP, GLP, ISO, FDA, HC, OTC and safety guidelines
  • Solid knowledge of all laboratory equipment (e.g., Viscometer, ACS Color Computer, Vitek, Analytical Instrumentation)
  • Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications
  • Effective communication and coaching skills. This includes the ability to communicate with the Quality Control lab team members clearly and concisely regarding quality issues, quality requirements, implementation of quality programs, and corrective & preventative actions where required. Ability to communicate information to cross-functional stakeholders and suppliers.
  • Strong problem solving skills
  • Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred
  • Knowledge of LIMS and its use, preference to LABWARE

Job Type: Full-time

Experience:

  • relevant: 2 years (Preferred)
  • Microbiology: 2 years (Required)
  • Manufacturing: 2 years (Required)

Education:

  • Bachelor's (Preferred)

Additional Compensation:

  • Bonuses

Work Location:

  • One location

Benefits:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Retirement plan
  • Paid time off
  • Parental leave
  • Professional development assistance
  • Tuition reimbursement

This Job Is:

  • A job for which military experienced candidates are encouraged to apply


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