Job Description

Role Summary

Reporting to the QC NPI Supervisor, the QC Lead Weekend Shift is primarily a hands-on analytical role, conducting and supporting complex analytical testing and method transfer work. The remaining portion of the role carries weekend team leadership and quality coverage responsibilities, drawing from the QC NPI Supervisor and QC Supervisor functions.

The QC Lead conducts analytical testing of raw materials, in-process materials, finished products, stability samples, and packaging components, and supports method transfer, verification, and validation activities for new product launches. During weekend shifts, this role also provides working leadership to the QC laboratory team Chemical Analysts and QC Technicians ensuring compliance with cGMP, SOPs, and Bimeda quality standards, and serving as the point of contact for lab oversight in the absence of the QC NPI Supervisor.

Shift Availability: Friday-Saturday-Sunday -Monday : 10Hrs.

Key Role Specific Requirements

• Conducts analytical (physical and chemical) testing of raw materials, in-process materials, finished products, stability samples, and packaging components using wet chemistry and chromatography instrumentation techniques.
• Conducts complex analytical testing utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF, and other laboratory instrumentation.
• Able to work directly from the USP or EP pharmacopeia to write protocols and execute methods; assesses, compares, and performs risk assessments for compendial method compliance according to USP, EP, and other applicable regulations.
• Verifies and processes analytical data for method transfer; writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, and method transfer protocols and reports.
• Supports NPI method transfer projects, working closely with R&D, QC Analysts, and the NPI team to meet product transfer timelines and quality requirements.
• Reviews laboratory documentation – notebooks, attachments, chromatography software, and specification sheets – for accuracy, completeness, and compliance with SOPs, specifications, and methods.
• Initiates deviations and investigations for applicable nonconformances; works with other departments and contributes to QC investigations to ensure accuracy and completeness of out-of-specification, out-of-trend, deviation, incident, and non-conformance events. Writes reports as required.
• Provides training, technical support, and expertise to QC Analysts, and supports department GMP compliance items as needed.
• Responsible for lab operations, safety, and schedules for the weekend team; supervises assignments and activity for Chemical Analysts and QC Technicians during the weekend shift.
• Collaborates with the QC NPI Supervisor and other internal departments on a regular basis to gain oversight of weekly manufacturing production and final release product planning, and assists in creating the test schedule for the QC team.
• Acts as the primary point of contact for laboratory investigations with internal and external auditors and regulatory inspectors during weekend shifts, in the absence of the QC NPI Supervisor.
• Ensures all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP/GLP), and Standard Operating Procedures (SOPs), escalating related issues to the QC NPI Supervisor in a timely manner.
• Provides independent oversight on the production floor, verifying that manufacturing activities are performed in accordance with approved procedures, specifications, and regulatory expectations. This includes but is not limited to, Line clearance activities, In process and final QA checks AQL checks and Provide support and guidance for failure events.
• Other duties as assigned.

This job description is not exhaustive; the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be amended over time as the role develops and as Bimeda's 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.

CREATIVITY AND INNOVATION - is the ability to create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage. Also, the ability to transcend traditional ideas, rules, patterns, relationships, or the like, and to create meaningful new ideas, forms, methods, or interpretations.

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 employees’ 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.

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.

Other Requirements

• Bachelor of Science degree in Chemistry, Biochemistry, or a related scientific discipline.
• 5–7 years of experience in a pharmaceutical analytical testing lab and supporting stability programs, including experience with method verification, method transfer, and method validation procedures.
• 2–3 years of experience in a leadership, senior, or working-lead capacity preferred, ideally within a GMP-regulated environment.
• Analytical Wet Chemistry Lab expertise using the following methods/equipment: titration, pH, potency, conductivity, viscosity, TOC, UV, IR, GC, HPLC/UPLC.
• Demonstrated leadership qualities to build teams, motivate employees, and provide positive reinforcement.

Demonstrated understanding of continuous improvement principles and the ability to recognize when change is needed and drive that change by removing barriers.

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 eight 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

More Info at Bimeda Careers