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Corden Pharma - A Full-Service CDMO
Corden Pharma - A Full-Service CDMO
1.001 – 5.000 Angajați
Asistență medicalăIndustria prelucrătoareProduse farmaceutice
Corden Pharma - A Full-Service CDMO este o organizație globală de dezvoltare și producție farmaceutică pe bază de contract, care deservește clienți de la programele clinice timpurii până la producția comercială. Capacitățile sale integrate includ ingrediente farmaceutice active (API), produse medicamentoase și excipienți lipidici, cu expertiză specializată în peptide, oligonucleotide, formulări cu nanoparticule lipidice (LNP), compuși foarte potenți și compuși oncologici, forme farmaceutice sterile și nesterile, precum și producția personalizată de lipide. Compania sprijină dezvoltarea și furnizarea de produse farmaceutice prin facilități conforme cu cerințele cGMP din Europa și America de Nord, combinând serviciile tehnice de producție cu managementul integrat al proiectelor.
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Locurile de muncă ale companiei

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.

USStatele Unite ale AmericiiCOColorado
33 $ – 43 $ / oră
La sediuNormă întreagăSeniorLimbă Obligatorie: englezăAnalist

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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

Locuri de muncă similare

Terumo Medical Corporation

Region Manager, Terumo Interventional Systems Sales

Terumo Medical Corporation
1.001 – 5.000 Angajați
Sponsor pentru viza H1BAsistență medicalăConsultanțăIndustria prelucrătoare
USStatele Unite ale AmericiiNJNew Jersey
120.000 $ – 165.000 $ / an
La sediuNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăManager

Lead medical device sales across a North Central New Jersey region, managing field teams and hospital relationships. Drive regional revenue, sales performance, and compliant promotion of Terumo Interventional Systems products.

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