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Corden Pharma - A Full-Service CDMO — ерте клиникалық бағдарламалардан бастап коммерциялық өндіріске дейін клиенттерге қызмет көрсететін жаһандық фармацевтикалық келісімшарттық әзірлеу және өндіру ұйымы. Оның біріктірілген мүмкіндіктері белсенді фармацевтикалық субстанцияларды (API), дәрілік препараттарды және липидтік қосымша заттарды қамтиды. Компания пептидтер, олигонуклеотидтер, липидтік нанобөлшектер (LNP) формуляциясы, жоғары уытты және онкологиялық қосылыстар, стерильді және стерильді емес дәрілік түрлер, сондай-ақ арнайы липидтер өндіру бағыттарында маманданған. Еуропа мен Солтүстік Америкадағы cGMP нысандары арқылы фармацевтикалық әзірлеу мен жеткізуді қолдап, техникалық өндірістік қызметтерді жобаларды кешенді басқарумен ұштастырады.
Senior IPC QC Analyst
Perform routine and advanced quality control testing at Corden Pharma’s Boulder pharmaceutical manufacturing site. Maintain GMP compliance, troubleshoot laboratory instruments, and review analytical data.
Сипаттама
- Analyze routine and non-routine samples using routine and advanced methods
- Partner with Process and QC Chemists to resolve issues and train new technicians
- Calibrate equipment, standardize titrants, and validate standards
- Identify and resolve QC laboratory instrument issues
- Report process, procedure, and material issues and proposed solutions to QC Chemists
- Investigate anomalous test results and take corrective action
- Keep the laboratory clean and organized in line with safety, regulatory, and chemical hygiene policies
- Troubleshoot QC laboratory instruments and analytical methods
- Complete daily records in SAP and LIMS
- Print labels, review certificates of analysis, and approve final products
- Compile data for statistical process control and modify LIMS
- Conduct peer reviews of analytical data
- Manage the generation and accumulation of hazardous and non-hazardous waste
- Attend QC team meetings and build team skills
- Lead the shift when management is absent
- Write and revise SOPs and methods as assigned
- Support cGMP-compliant pharmaceutical manufacturing within Corden Pharma Colorado’s Quality Management System
Талаптар
- Hold a bachelor’s degree in a related science and have five years of GMP experience in a quality laboratory; alternatively, have five years of related experience in a quality environment or an equivalent combination of education and experience
- Read and interpret safety rules, operating and maintenance instructions, and procedure manuals
- Write routine reports and correspondence
- Speak effectively to groups of customers or employees
- Work with probability, statistical inference, geometry, trigonometry, fractions, percentages, ratios, and proportions
- Solve practical problems and interpret written, oral, diagram, or schedule instructions
- Bring strong analytical skills and knowledge of general or organic chemistry
- Apply specialized skills to non-routine methods
- Demonstrate mechanical aptitude with laboratory equipment
- Analyze data at an advanced level and detect errors
- Demonstrate problem-solving skills
- Commit to QSHE principles
- Write and revise SOPs and methods as directed
- Use laboratory software at an advanced level
- Work 12-hour rotating day or night shifts, including weekends and holidays
- Use word processing, spreadsheets, email, and database applications confidently
- Occasionally lift and/or move up to 25 pounds
- Comply with safety, regulatory, chemical hygiene, GLP, GMP, FDA, ICH Q7, and applicable global regulatory requirements
Артықшылықтар
- 401(k) matching: Corden Pharma contributes 100% of the first 6%; fully vested after two years of service
- Accident plan
- Critical illness insurance
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- PPO/HSA health insurance
- Hospital indemnity plan
- Identity theft protection
- Life insurance
- Paid parental leave
- Tuition reimbursement
- Wellness program
- Three weeks of vacation in the first year
- Vision insurance
Ұқсас жұмыс орындары
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