Connetics Corp Work Values

Daily Duties at Connetics Corp:

 Coordinate all Quality Control activities which involved assays for drug substance and drug products  Develop protocols for Stability Studies and Method Validation  Active participant in the writing of CMC sections of regulatory dossiers  Support both the Process Development and Formulations groups with their work in developing, testing and transferring processes to a manufacturing environment.  Developed Chromatography methods of analyses for drug product, drug substance, compendial and non-compendial methods.  Perform all Stability Studies for lot release batches of drug product.  Maintain all Hardware and Software systems within compliance according to 21 CFR pt 211/11 (Specifically, I coordinated all IQ, OQ and PM compliance events)  Technology Transfer: LC methods created for the purpose of stability studies were transferred to off-site contractors.  Act as a Liaison between the analytical group and other groups within Connetics and at our partner contractors  Conduct OOS investigations when necessary.  Maintain a cGMP environment within our QC testing lab.  Help in the hiring and training of staff  Participate in Audits conducted by the QA unit or FDA.  Participate in inter departmental meetings and discussions  Experience in IEF and SDS PAGE gel electrophoresis.

What they like about Connetics Corp:

You highly value a work environment built on a formal structure, rules, and regulations. You do not enjoy the unpredictability of shifting priorities and deadlines that upset your routine. You require and enjoy direction, input and accountability as part of your work environment. You have a strong need to participate in making key decisions and feel left out if your superiors or co-workers do not seek your input when making decisions. You thrive on providing good customer service to both internal or external customers, and doing so makes you feel good.

Tags

Quality Control, Stability, Analytical chemistry, Project management, Method Development, Method validation, management, Lead chemist, Sr QC Associate, Sr. QC Chemist, Audits, Compliance, research Associate, IND, NDA, PAS, BLA, Submissions, Chromatography, San Francisco, South San Francisco, Oakland, Seattle, Bothell, San Diego

Skills

Software Implementation, Leadership , Chemist, QC Associate, method development, method validation, IQ/OQ/PQ, Audits, CMOs, Quality Agreements, QC Stability, supervisorial, managerial, Director, cross training, submission writing, data review, trending, LIMS, chromatography, JMP Software, Kaleidograph, Chemstation, Chemsystem, Millenium, Excalibur, Trackwise, Novaweb, Novamanage, empower, PeakPro, POMS Lot Trace, presentations CMC-RAC CMC-ARC, ARs APRs, investigate OOS/OOT and CAPAs, method transfer, Represent my team at cross functional meetings

These are some of the questions we asked our climbers about their experiences with Connetics Corp: