QC Supervisor (Afternoon Shift)

Role Summary

Reporting to the Quality Control Manager, the QC Supervisor oversees the chemical analysis of raw materials, in-process, finished product and stability samples and ensures that testing results provide the highest quality support for manufacturing in compliance to cGMP, SOPs and Bimeda quality standards. This position supervises the performance of the Chemical Analysts I, II and III and QC technicians on the afternoon shift.

Shift availability : Afternoon , Monday - Friday , 3:00pm- 11:30pm

Key Role Responsibilities

• 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.
  
  

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

BUILDING RELATIONSHIPS – is the process of developing social connections. This is a fundamental business competency that is the basis for reputation, influencing, closing deals and sustaining business relationships.

LEADERSHIP – is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high -performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provides direction with purpose and alignment to Company vision and values.

ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.

ENGAGEMENT, DRIVE AND EMPOWERMENT - The ability to convey confidence in employee’s ability to be successful, especially at challenging new tasks; delegating significant responsibility and authority to engage employees; allowing employees freedom to decide how they will accomplish their goals and resolve issues.

Essential

Other Requirements

• 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.
  
  

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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