Leading Cosmetics company is looking for a Quality Assurance Lab Specialist to join the team in Scarborough.
Location: Sheppard Ave E and McCowan Rd
- 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 of lab testing processes with the ability to troubleshoot instruments and issues and provide guidance and coaching on GMP/GLP practices in the laboratory.
- Responsible for performing quarterly APR reports for lab testing data, OOS and stability reports, following up with other Quality groups to incorporate their data, compiling summaries and routing completed reports for approval.
- Responsible for completing audit trail reviews on GxP lab equipment.
- Provide assistance and guidance for all OOS investigations with ownership for the design and administration of the investigation process.
- Review and provide assistance and guidance for lab-related deviations, CAPAs, change controls, validation protocols and reports. Support projects that improve testing harmonization and workflow efficiencies in conjunction with lab leadership.
- Develop training programs and materials and monitor for compliance.
- 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 with good manufacturing and lab practices.
- Execution of data integrity checks/verifications
- 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 the 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 an SME for Internal audits, corporate audits, FDA inspections, etc
Oversight of OC Lab Testing
- 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.
- Provide guidance to the Quality Control team in handling deviations/CAPAs, changes, incidents, and laboratory investigations
- 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.
- Review and approval of lab equipment change controls
- 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.
- 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
- Minimum 3 years of working experience
- Minimum education level: 4 year degree or equivalent experience
- Experience in Fast Paced Consumer Goods manufacturing environment a plus (Cosmetic, Food,or Pharma)
Ability to interpret and assess operational compliance against Good Manufacturing Practice Regulations (FDA, KFDA, HC, ISO22716)
- Ability to execute and coach teams in root cause problem solving and associated Corrective and Preventive Actions (CAPA)
- Ability to identify and drive process improvement opportunities by partnering with cross-functional stakeholders
- Ability to execute, summarize and manage process audits in the manufacturing areas
- Effective oral and written communication skills and ability to appropriately communicate information to cross-functional stakeholders and suppliers
- Knowledge and ability to execute statistical sampling, AQL/ANSI interpretation, and read/interpret specifications, drawings and compounding/assembly instructions
- Ability to utilize standard tools and equipment (such as scale, fill weight, cap torque, viscometer, pH meter, pull force, seal burst, and other relevant equipment)
- Ability to review SOP’s, GMP reports, batch records and investigations
Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred
How to Apply
Send your resume to firstname.lastname@example.org with the subject "Quality Assurance Lab Specialist_Scarborough"