QC Analyst III - Full Time (10 Hours Shift)

Bimeda; Cambridge; On-site; CAD 60,000 - 90,000; Full time

Job summary

An established industry player seeks a QC Analyst III to join their innovative team. In this pivotal role, you will leverage your expertise in pharmaceutical chemistry to conduct complex analyses and ensure compliance with stringent quality standards. You will play a key role in supporting new product launches and method transfers, while also mentoring junior analysts. This position offers a unique opportunity to contribute to the development of high-quality veterinary pharmaceuticals in a collaborative environment. If you are passionate about quality assurance and thrive in a dynamic setting, this role is designed for you.

Qualifications

• 5-7 years experience in a Pharmaceutical Analytical testing lab.
• Expertise in analytical tests using various laboratory instruments.

Responsibilities

• Conducts analytical testing of raw materials and finished products.
• Leads investigations for deviations and non-conformances.

Skills

HPLC/UPLC

GC

Analytical Chemistry

Wet Chemistry Techniques

Pharmaceutical Testing

Education

B.Sc. in Chemistry

B.Sc. in Biochemistry

Tools

UV Spectroscopy

IR Spectroscopy

FTIR

Titration

Job description

Role Summary

Reporting to the QC Project Lead, the role is responsible for analysis of raw materials, in-process and finished products, stability samples, and packaging components using various instrumentation and wet chemistry techniques. The role works in compliance with cGMP, SOPs, and Bimeda quality standards.

Additionally, in support of Bimeda’s new product launches, the QC Analyst III is responsible for method transfers for new product developments, new API sources, technical transfers, and other related activities.

The QC Analyst III is a subject matter expert in pharmaceutical chemistry testing and responsible for the department’s more complex analyses using various wet chemistry and chromatography instrumentation techniques while ensuring compliance with cGMP, SOPs, and Bimeda quality standards.

The QC Analyst III also provides support to QC Analysts through training, technical support & expertise, and supports department GMP compliance issues as needed.

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

Key Role Specific Requirements

• Ensures that all work is carried out in compliance with company Safety policies, GMP/GLP, and SOPs.
• Responsible for lab operations, safety, and schedules for their team.
• Expertise with analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF, and other laboratory instruments.
• Supports QC Analysts through training, technical support & expertise, and supports department GMP compliance items as needed.
• Conducts analytical (physical & chemical) testing of raw materials, in-process & finished products, stability samples, and packaging components.
• Leads by example and proactively communicates and collaborates with internal staff and colleagues to achieve objectives.
• Contributes and leads departmental CR/OOS/CAPA/Deviations.
• Collaborates with the QC management team and other internal departments on a regular basis to gain oversight on weekly manufacturing production / final release product planning and assists in creating the test schedule for the QC team.
• Initiates deviations and investigations 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, incident reports, and non-conformances.
• Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods, and assess, compare, and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
• Reviews laboratory documentation in notebooks, attachments, chromatography software, and specification sheets for accuracy, completeness, and compliance with established SOPs, specifications, and methods.
• Conducts investigation of deviations, OOS, and non-conformances. Writes reports as required.
• Verifies and processes analytical data for method transfer. Writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, method transfer protocols and reports.
• 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. Activities may be subject to change over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role

• INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable, and trustworthy.
• FOSTERING COLLABORATION/TEAMWORK – Ability to work jointly with others, especially in an intellectual endeavor; to work cooperatively with others on a team; to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
• INITIATIVE – Identifying what needs to be done and doing it proactively.
• THOROUGHNESS/DETAIL ORIENTED – Ensuring that work and information are complete and accurate; carefully preparing for meetings and follow-ups.
• PLANNING – Organizing activities to achieve goals.

Other Requirements

5-7 years in a Pharmaceutical Analytical testing lab & supporting stability programs.

B.Sc. in Chemistry, Biochemistry, or related discipline.

Analytical Wet Chemistry Lab experience using titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC assays.

About Bimeda

Bimeda is a leading global innovator, manufacturer, and marketer of veterinary pharmaceuticals and animal health products with over half a century of experience. It has multiple R&D centers and manufacturing facilities worldwide, focusing on quality Bimeda-branded products and contract manufacturing services.

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