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Quality Control Chemistry Specialist II
2 months ago
A career at National Resilience is more than just a job – it's an opportunity to change the future.
National Resilience is a technology-driven biomanufacturing organization that is transforming the production of medicine. We are establishing a sustainable network of advanced manufacturing solutions to better withstand disruptive events, support scientific discovery, and reach those in need.
Position Overview:
The Specialist II, QC Chemistry will be tasked with the evaluation of in-process materials, validation, stability, and final products for biochemical assessment in accordance with cGMP and organizational specifications. Duties also encompass reviewing, troubleshooting, maintaining instruments, drafting protocols/reports, and cross-training other QC Chemistry analysts.
Key Responsibilities:
- Conduct sample analysis utilizing bioanalytical test methods such as HPLC, UPLC, BCA, SDS-PAGE, ELISA, Western blot, and UV-Vis, following SOPs and/or protocols.
- Perform routine maintenance on laboratory instruments.
- Adhere to established procedures for chemical receipt, inventory management, usage, and disposal.
- Troubleshoot methodologies and equipment as necessary.
- Draft SOP and QCP methods, managing them through change control.
- Lead and execute instrument qualification tasks as required.
- Review test worksheets, including raw data and audit trails.
- Develop and implement QC studies and prepare reports.
- Engage in scheduled cleaning and other laboratory housekeeping responsibilities.
- Employ sound documentation practices when generating raw data, reports, SOPs, and other documentation.
- Author lab investigations in collaboration with supervisors when necessary.
- Notify supervisors of any deviations from organizational procedures or discrepancies that may impact product quality or cGMP compliance according to established protocols.
- Perform additional routine testing and training to support analytical testing needs in the laboratory.
- Ensure that documentation is accurate and current.
- Once qualified as a trainer, conduct cross-training for other QC analysts.
- Identify and lead corrective action initiatives, participate in root cause analysis, and communicate with other departments regarding ongoing issues.
- Execute other job-related tasks as assigned.
- Comprehensive understanding of GMP and GLP.
- Advanced knowledge and practical experience in protein analysis techniques such as BCA, Western blot, SDS-PAGE, ELISA, and concentration analysis using UV-Vis Spectrophotometer, HPLC/UPLC.
- Proficiency in data analysis, statistics, and report preparation with familiarity in MS Word, Excel, and Outlook.
- Advanced knowledge of compendial test requirements, US and European Pharmacopeia.
- Strong attention to detail, self-motivated, highly organized, and capable of thriving in a fast-paced laboratory environment.
- Able to manage multiple tasks effectively.
- Ability to quickly learn new bioanalytical techniques.
- Excellent verbal and written communication skills (technical writing/protocols/reports).
- Strong presentation abilities.
- Bachelor's degree in Biochemistry/Chemistry, 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 an added advantage.
- Pre-employment medical and periodic medical re-examinations, including eye examinations and color blindness tests, conducted every two years or as per organizational SOPs.
- This position requires vaccination for Hepatitis A and B.
- Job entails shift work, weekends, and occasional extended shifts with possible short notice schedule changes.
- Demonstrated ability to apply the following behavioral competencies on the job:
- Teamwork: Collaborating effectively and productively with others.
- 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. Ability to work independently.
- Goal Orientation: Focusing efforts energetically on achieving objectives.
- Written Communication: Writing clearly, succinctly, and understandably.
- Decision Making: Utilizing effective processes to make timely decisions.
- Organization and Planning: Employing logical, systematic, and orderly procedures to meet objectives.
This job profile provides an overview of the minimum requirements of the position and does not encompass all duties inherent, included, or associated with the role or its performance. The organization reserves the right to modify the job profile as necessary to meet its needs.
National Resilience is committed to providing accessible employment practices that comply with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are encouraged to communicate their needs/requirements to Human Resources.
National Resilience offers a comprehensive total rewards program, including equity, an annual cash bonus program, a RRSP/DPSP with a generous company match, a competitive healthcare, dental, vision, life, LTD, and AD&D benefits package, fertility healthcare and family-forming benefits, flexible time off, paid holidays, pregnancy and parental leave top-up plan, tuition reimbursement, and an employee referral program. Our target base pay hiring range for this position is $60,000 to $78,750. Actual base pay is determined by various factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills, and knowledge. Excited about National Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
