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Senior QC Analyst
Corden Pharma - A Full-Service CDMO. Run routine and advanced analyses on non-routine samples .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced analytical skills and knowledge of general or organic chemistry, with a strong focus on GMP compliance and quality assurance in laboratory settings. Proficient in troubleshooting laboratory instrumentation and methods while maintaining adherence to safety and regulatory standards.
Highest-signal resume keywords
GMP ExperienceAnalytical Data AnalysisLaboratory Software ProficiencyProblem-Solving SkillsSOP Writing and Revision
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Analytical SkillsGeneral Chemistry KnowledgeNon-Routine Methods ExpertiseLaboratory Equipment CalibrationStatistical Process ControlData CompilationMethod Transfers and ValidationsRecord Keeping in SAPLIMS ModificationsMechanical Aptitude
Soft Skills
Good Communication SkillsPresentation SkillsSelf-DirectionTeam CollaborationProblem-Solving Skills
Tools & Technologies
SAPLIMSStatistical SoftwareQuality Management System
Industry Keywords
GMPGLPFDA RegulationsICH Q7Chemical HygieneQuality AssuranceQC LaboratoryHazardous Waste ManagementQuality ControlLaboratory Safety
About the role
Key responsibilities & impact- Run routine and advanced analyses on non-routine samples
- Work with Process Chemists and QC Chemists to resolve problems and train new technicians
- Perform equipment calibration, titrant standardization, and standard validation
- Identify and correct QC laboratory instrument problems
- Identify and communicate problems and solutions related to processes, procedures, and materials to the QC Chemist
- Research and take corrective action on anomalous test results
- Maintain laboratory cleanliness and organization while following safety, regulatory, chemical hygiene, GLP, and GMP policies
- Troubleshoot QC laboratory instrumentation and methods
- Complete daily record keeping in SAP and LIMS
- Print labels, review certificates of analysis, and approve final product
- Gather and compile data for statistical process control and perform LIMS modifications
- Peer review analytical data
- Manage hazardous and non-hazardous waste generation and accumulation
- Attend QC team meetings and develop team skills
- Act as Shift Lead in the absence of management
- Follow Corden Pharma Colorado's cGMP-based Quality Management System and applicable FDA, ICH Q7, and other regulations
- Take ownership of actions and work toward organizational results and goals
Requirements
What you’ll need- Bachelor's Degree from a 4-year college or university in a related science area and 5 years of GMP experience in a Quality Lab; or Master's Degree from a college or university and 2 years GMP experience in a Quality Lab; or 5 years of related experience in a Quality environment; or equivalent combination of education and experience
- Highly developed analytical skills and knowledge of general or organic chemistry
- Specialized skills on non-routine methods
- Ability to demonstrate self-direction in the absence of immediate supervision
- Mechanical aptitude with lab equipment
- Advanced analytical data analysis with ability to detect errors
- General laboratory skills
- Good communication and presentation skills
- Demonstrated problem-solving skills
- Commitment to QSHE Principles
- Ability to write and revise SOPs and methods as directed
- Advanced understanding of laboratory software
- Review of analytical data
- Review and execution of method transfers and validations
- Ability to work 12-hour rotating shifts, night or day; weekends and holidays required
- Strong computer skills including word processing, spreadsheets, e-mail, and database applications
- Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals
- Ability to write routine reports and correspondence
- Ability to speak effectively before groups of customers or employees
- Ability to work with probability, statistical inference, geometry, trigonometry, fractions, percentages, ratios, and proportions
- Ability to solve practical problems and interpret written, oral, diagram, or schedule instructions
- Must occasionally lift and/or move up to 25 pounds
- Certificates, licenses, registrations: None
Benefits
Comp & perks- 401(k) matching - Corden Pharma will contribute 100% of the first 6%; 100% vested after 2 years of service
- Accident Plan
- Critical Illness Insurance
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft Protection
- Life Insurance
- Paid Parental Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance