QC Lab Manager - Analytical
Shift: 4 on / 4 off
Description. My client is seeking a QC Lab Manager - Analytical within the QC Department. This will be overseeing lab testing and with the ability to trouble-shoot. As well as, support the Senior Manager, QC Lab for a particular shift and/or lab function in planning, organizing, implementing and controlling the daily activities of the QC laboratory to ascertain that raw materials, mass and finished goods meet internal and external specifications.
Key Responsibilites include:
Management of QC Lab Testing for a shift or lab function
Plan, organise, implement and control the daily activities of the QC laboratory to ascertain that both raw materials and assay of finished goods / mass meet internal and external specification. This includes management for lab workflow, sample analysis, sample retention, standards management, raw material qualification, TPM testing, outsourced testing, inventory management and document management
Ensure execution of data integrity checks / verifications per procedures
Provide QC expertise to plant hygiene program and lead corrective action based on findings
Ensure there is testing support in relation to the environmental monitoring program and any associated risk assessments
Identify SOPs and support the Senior Manager, QC Lab in work instruction updates or creating new based on lab trends and CAPAs.
Review SOPs and work instructions and provide to QC Lab Lead for approval.
Review and trending of OOS, CAPAs and deviations related to their QC lab function
Testing Data Review and Release - Data Reviewer role responsibilities
Review routine supporting test data and results, including sample preparation records, chromatograms / graphs, logbooks, calculations, and data sheets. Enter results in SAP/LIMS.
Release raw materials, non-OTC mass, and Cosmetic FGs in SAP
Review non-routine supporting test data and results (i.e. micro testing for water systems, validation testing)
Manage QC lab equipment budget, equipment purchases, installation and initiate change control as needed
Develop lab equipment qualification (IQ/OQ/PQ) protocols and reports
Manage specific area’s equipment administration, including calibration, preventive maintenance, and troubleshooting as needed
Compliance / Continuous Improvement within Lab Function Area
Ensure all lab processes are adhering to relevant regulatory GMPs and global company policies & procedures
Participate in internal audits to ensure regulatory readiness
Work collaboratively with Planning, GBSC, QA Labs, Manufacturing, Validation, and Operations to drive continuous improvement.
Monitor lab KPIs and drive improvements
Ensure all customer complaints are investigated, improvements implemented and response made in a timely manner
Support Plant and Global programmes to ensure compliance in key areas including Good Manufacturing Practices, Data Integrity, and the General Data Protection Regulation (GDPR).
Personnel Management & Training
Apply QC Lab objectives to their lab function area and conduct performance reviews against those objectives.
Provide the coaching, mentorship and training necessary to support ongoing personal and professional development of QC lab staff (GMP and refresher training)
Assist in the development and execution of quality training curriculum for the laboratory.
Five years’ laboratory experience, with at least three years in a supervisory position, preferably in microbiology, analytical chemistry or product evaluation laboratories in Quality Control for a global consumer goods or pharmaceutical company
Experience in developing laboratory SOPs and revisions according to regulatory guidelines
Effective oral and written communication skills and ability to appropriately communicate information to cross functional stakeholders and suppliers
Strong knowledge of GMP, ISO and safety guidelines
Solid knowledge of all laboratory equipment (e.g., Viscometer, ACS Color Computer, Vitek, Analytical Instrumentation)
Strong problem-solving skills
Knowledge of statistical assessments of data
Proficiency in Microsoft Office Suite, Electronic QMS, and SAP systems is preferred
Flexible to support off-shift work when needed.