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Specialist II, QC Chemistry
3 months ago
A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Job Summary:
The Specialist II, QC Chemistry will be responsible for testing in-process materials, validation, stability, and final products for bio-chemical assessment according to cGMP and company specifications. Responsibilities also include reviewing, troubleshooting, instrument maintenance, writing protocols/reports as well as cross-training of other QC Chemistry analysts.
Job Responsibilities:
- Perform sample analysis using bioanalytical test methods such as HPLC, UPLC, BCA, SDS-PAGE, ELISA, Western blot and UV-Vis, as per SOPs and/or protocols.
- Perform routine maintenance on laboratory instruments.
- Follow established procedures for chemical receipt, inventory, use and discard.
- Troubleshoot methods and equipment as required.
- Author SOP and QCP methods, and manage through change control.
- Lead and execute instrument qualification work as required.
- Review test worksheets including raw data and audit trails.
- Develop and execute QC studies and write reports.
- Participate in scheduled cleaning and other laboratory housekeeping duties.
- Employ good documentation practices when generating raw data, reports, SOPs and other documentation.
- Author lab investigations with supervisor when required.
- Report to supervisor any deviations from company procedures, or other discrepancies that may affect product quality or cGMP status according to established procedures.
- Perform other routine testing and training to support analytical testing requirements in the lab.
- Ensure documentations are accurate and up to date.
- Once qualified as a trainer, perform cross training of other QC analysts.
- Identify and lead corrective action plans, participate in identifying root causes and communicate with other departments regarding pending issues.
- Perform other job-related duties as assigned.
- Strong understanding of GMP and GLP.
- Advanced knowledge and practical experience in protein analysis such as BCA, Western blot, SDS-PAGE, ELISA, concentration analysis using UV-Vis Spectrophotometer, HPLC/UPLC.
- Data analysis, statistics, and report preparation with knowledge of MS Word, Excel and Outlook.
- Advanced knowledge of compendial test requirements, US and Europe Pharmacopeia.
- Strong attention to detail, self-motivated, highly organized, and able to work in the fast-paced laboratory environment.
- Able to multi-task.
- Ability to learn new bioanalytical techniques quickly.
- Good verbal and written communication (technical writing/protocols/reports).
- Strong presentation skills.
- Bachelor’s degree in Biochemistry/Chemistry, or Chemical Engineering or College Diploma in Biotechnology, Chemical Engineering Technology or Chemical Laboratory Technology, with at least 3-5 years related experience in a quality lab environment (biologics/pharmaceutical preferred) or Master’s degree with 2-3 years’ related experience.
- Working experience with HPLC will be an added advantage.
- Pre-employment medical and medical re-examination; inclusive of eye examination and colour blindness test, performed every 2 years or as per Resilience’s SOPs.
- This position requires vaccination for Hepatitis A and B.
- Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shift changes.
- Demonstrated ability to apply the following behavioural competencies on the job:
- Teamwork: Working effectively and productively with others.
- Interpersonal Skills: Effectively communicating, building rapport, and relating well to all personality types.
- Problem Solving: Anticipating, analysing, diagnosing, and resolving problems.
- Flexibility: Agility in adapting to change. Ability to work independently.
- Goal Orientation: Energetically focusing efforts on meeting a goal, mission, or objective.
- Written Communication: Writing clearly, succinctly, and understandably.
- Decision Making: Utilizing effective processes to make timely decisions.
- Organization and Planning: Utilizing logical, systematic, and orderly procedures to meet objectives.
This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The Company reserves the right to make changes to the job profile as it sees fit to meet the needs of the organization.
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