Responsibilities include but are not limited to:
- Supervises the QC testing laboratory staff and oversees the processes for analytical testing of raw materials, in-process, finished product and stability samples
- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and escalates related issues to QC Manager on timely manner.
- Achieves results through direct reports by communicating job expectations; establishing individual goals in line with departmental objectives, coaching, reviewing performance results; holding accountable; providing cross training opportunities for skill development
- Leads by example and proactively communicates and collaborates with internal staff and colleagues to achieve objectives.
- Reviews laboratory documentation in notebooks, attachments, chromatography software, and specification sheets for accuracy, completeness, and compliance with established SOPs, specifications and methods.
- Review stability protocols for scale-up and ANA/NDA products.
- Collaborates with the internal departments and other shift QC Supervisor on a regular basis to gain oversight on the weekly manufacturing production / final release product planning and assists in the creation of the test schedule for the QC team.
- Oversee calibration program and ensue timely completion.
- Compiles data to trend and monitor key department performance metrics and provides reports to manager as required
- Initiates deviation reports for any applicable nonconformances. Works with other departments and leads QC investigations to ensure accuracy and completeness of out-of-specifications, out-of-trends, deviations, and non-conformances
- Oversees the training of laboratory staff on newly written or revised methods and procedures
- Acts as the primary point of contact for laboratory investigations information with internal and external auditors and regulatory inspectors in the absence for the QC Manager.
- Leads in the implementation of continuous quality improvements, CAPEX projects and lean laboratory initiatives in accordance with GLP
- Develops, reviews and revises laboratory documentation as required. Initiates change control documents as required
- Ensure safety, health and environmental procedures are given due priority. Identify, investigate, correct and document potential environmental and safety problems
- Other duties as assigned
Required Knowledge, Skills & Abilities
- 5 years of work experience in an Analytical testing lab with 2-3 years in a leadership or senior role
- 2 years work experience in pharmaceutical preferred
- BSc degree in Chemistry or related science
- Subject Matter expert in Analytical chemistry with experience utilizing the following equipment: auto-titrator, pH, conductivity meter, TOC, UV, IR, GC, HPLC required
- Demonstrated leadership qualities to build teams, motivate employees, positive reinforcement
- Demonstrated understanding of continuous improvement and ability to recognize when change is needed and drive the change by removing barriers to change
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.