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Quality Control Chemistry Specialist II
2 months ago
A career at National Resilience presents an opportunity to influence the future of biomanufacturing.
National Resilience is at the forefront of technology-driven biomanufacturing, transforming the landscape of medicine production. We are developing a resilient network of advanced manufacturing solutions designed to endure disruptive challenges, support scientific innovation, and meet the needs of patients.
Position Overview:
The Specialist II in Quality Control Chemistry is tasked with the assessment of in-process materials, validation, stability, and final products for biochemical evaluation in accordance with cGMP and organizational standards. This role also encompasses reviewing processes, troubleshooting, maintaining instruments, and training other QC Chemistry personnel.
Key Responsibilities:
- Conduct sample evaluations utilizing bioanalytical methodologies such as HPLC, UPLC, BCA, SDS-PAGE, ELISA, Western blot, and UV-Vis, following established SOPs and protocols.
- Perform routine upkeep on laboratory equipment.
- Adhere to established protocols for the receipt, inventory, utilization, and disposal of chemicals.
- Diagnose and resolve issues with methods and equipment as necessary.
- Draft SOPs and QCP methods, managing them through change control processes.
- Lead and execute instrument qualification activities as required.
- Review test documentation, including raw data and audit trails.
- Design and implement QC studies, compiling comprehensive reports.
- Engage in scheduled cleaning and other laboratory maintenance tasks.
- Utilize sound documentation practices when generating raw data, reports, SOPs, and related documentation.
- Collaborate with supervisors to author lab investigations when necessary.
- Notify supervisors of any deviations from company protocols or discrepancies that could impact product quality or cGMP compliance.
- Conduct routine testing and training to support laboratory analytical requirements.
- Ensure all documentation is accurate and current.
- Once qualified, provide cross-training for other QC analysts.
- Identify and spearhead corrective action initiatives, participate in root cause analysis, and communicate with other departments regarding ongoing issues.
- Perform additional job-related duties as assigned.
- In-depth understanding of GMP and GLP standards.
- Extensive knowledge and hands-on experience in protein analysis techniques including BCA, Western blot, SDS-PAGE, ELISA, and concentration analysis via UV-Vis Spectrophotometer, HPLC/UPLC.
- Proficient in data analysis, statistics, and report generation with familiarity in MS Word, Excel, and Outlook.
- Advanced knowledge of compendial testing requirements, including US and European Pharmacopeia.
- Exceptional attention to detail, self-driven, highly organized, and capable of thriving in a dynamic laboratory setting.
- Able to manage multiple tasks simultaneously.
- Quick learner of new bioanalytical techniques.
- Strong verbal and written communication skills, including technical writing and report preparation.
- Excellent presentation abilities.
- Bachelor's degree in Biochemistry, Chemistry, or Chemical Engineering, or a College Diploma in Biotechnology, Chemical Engineering Technology, or Chemical Laboratory Technology, with a minimum of 3-5 years of relevant experience in a quality laboratory environment (biologics/pharmaceutical preferred) or a Master's degree with 2-3 years of related experience.
- Experience with HPLC is advantageous.
- Completion of pre-employment medical assessments, including eye examinations and color vision tests, conducted biennially or as per National Resilience's SOPs.
- This position mandates vaccination for Hepatitis A and B.
- Job entails shift work, including weekends and potential extended hours, with possible short-notice schedule changes.
- Demonstrated ability to embody the following behavioral competencies:
- Teamwork: Collaborating effectively and productively with colleagues.
- Interpersonal Skills: Communicating effectively, building rapport, and relating well to diverse personality types.
- Problem Solving: Anticipating, analyzing, diagnosing, and resolving issues.
- Flexibility: Adapting to change with agility and working independently.
- Goal Orientation: Focusing efforts energetically on achieving objectives.
- Written Communication: Writing clearly, concisely, and understandably.
- Decision Making: Employing effective processes for timely decision-making.
- Organization and Planning: Utilizing systematic and orderly procedures to meet goals.
This job profile outlines the minimum requirements for the position and does not encompass all duties inherent to the role or associated with job performance. The Company reserves the right to modify the job profile as necessary to fulfill organizational needs.
National Resilience is dedicated to ensuring accessible employment practices in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Accommodation requests can be made at any stage of the recruitment process. Applicants are encouraged to communicate their needs to Human Resources.
National Resilience offers a comprehensive total rewards program, including equity, an annual cash bonus, a RRSP/DPSP with a generous company match, competitive healthcare, dental, vision, life, LTD, and AD&D benefits, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up, tuition reimbursement, and an employee referral program. The target base pay hiring range for this position is $60,000 to $78,750 annually. Actual base pay is contingent upon various factors, including geographical location, relevant experience, qualifications, skills, and knowledge.
