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:

Working for a company with an emphasis on social values and helping society is a clear and important priority for you - a critical factor in who you choose to work for. In contrast to other factors, you place an organization's reputation for fairness and concern for the community above most other aspects of the company. As you search for a new job opportunity, it is usually possible to find out if the company is involved in the community and/or if it is addressing problems and issues in society. Pay special attention to non-profit organizations and those specifically involved in social action. Moreover, speaking with current and former employees should enlighten you to perceptions of the fairness of the company's leaders and the treatment of employees.

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: