Team Lead, Quality Control - Verona, WI
3 weeks ago
Job Summary
This position falls within the Quality Control structure under the Quality Assurance Organization The Team Leader IPCs Validations will manage chemists and help to support the analytical testing of pharmaceutical in process manufacturing samples and validation activities for drug substances and drug products while carrying out a supervisory function They will work cross functionally to identity and resolve any issues that ariseResponsibilities
- Management Provide leadership and guidance to a team of QC chemists ensuring their professional growth and development Set clear performance expectations provide regular feedback and conduct performance evaluations Foster a collaborative inclusive work environment that encourages teamwork creativity innovation Attend contribute to regular leadership meetings between cross functional departments Scientific Laboratory Fully knowledgeable of cGMP requirements ICH guidelines Frequently works independently to meet project timelines deliverables with minimal supervision no supervision Collaborates with Analytical Development on procedural method transfers may participate in execution of method validation protocols Proficient with various analytical instrumentation theory practice Executes training requirements assigned SOPs participates department specific training Demonstrates proficiency variety instrumentation e g HPLC GC LC MS KF FTIR Endotoxin plate readers Raman spectroscopy assists analyst training instrumentation as Subject matter expert technical aspects both instrumentation workflow management prioritization Works closely QA Analytical Development Manufacturing personnel efficient project execution timely accurate deliverables Trains mentors entry chemists mid level chemists Ability track trend data interpret degenerative changes product stability Leads assists scientific technical discussions brainstorming sessions Identifies troubleshoots analytical method issues instrumentation general chemistry test methodology sample product Communicates laboratory testing issues challenges senior laboratory management Maintains clear concise accurate notebook Drafts technical documents OOS/atypical investigations deviations CAPAs Possesses written verbal communication skills Embraces cGMP ICH requirements associated work Calibration maintenance troubleshooting analytical equipment collaboration metrology Routinely makes sound scientific decisions serves backup Senior Laboratory Management Other Skills Abilities Must able work people levels organization Basic knowledge computers PCs Ability use windows-based software including MS Office chromatography data collection software Must able solve practical problems Interpret instructions furnished written oral diagram schedule form Must able perform complex mathematical calculations compute ratios rate percent Must able draw interpret graphs charts Ability read analyze interpret SOPs test methods procedural guides associated technical documents Write clear concise manner Effectively present communicate information respond questions from management peers colleagues h2 bRequirements/b ul li Masters Chemistry related field years relevant laboratory experience Bachelor s Chemistry related field years relevant laboratory experience Fully knowledgeable cGMP ICH laboratory requirements operations Proficient demonstrated experience analytical instrumentation test methodology validations transfers data acquisition systems typical cGMP policies practices Arrowhead provides competitive salaries excellent benefit package All applicants must have authorization work US company California Applicant Privacy Policy p>
Job description
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