Senior QA Specialist
Proclinical is currently recruiting for a Senior QA Specialist with a biopharmaceutical company located in Oceanside, CA. A successful candidate must have extensive experience with LIMS, authoring protocols and technical documents, data/technical review, and sound knowledge of cGMPs/GLPs/GMPs. Bachelors is required.
- Link laboratory programs to LIMS for data upload, as well as continuously improve upon IT processes. Analytical to reduce turnaround time while also maintaining quality system requirements
- Manage and maintain LIMS static data such as user matrix, specifications, analysis, stability protocols, data tables and instruments
- Interact with the Laboratory operations group to support LIMS implementation and ongoing support
- Work with the IS and IT groups to integrate LIMS in a cGMP environment
- Independently plan, manage and execute assignments, contribute to project planning meetings
- Support all necessary aspects of LIMS projects and operations as assigned
- Partner with IT and laboratory organizations, support users by responding to change requests and training needs
- Assist in developing and maintaining Standard Operating Procedures (SOPs) for global and local Laboratory Information Management (LIMS) Systems
- Act as key project team member for new systems implementations and/or installation of new capabilities
- Provide system oversite activities including audit trail reviews, system reviews, resolution of problem reports, data maintenance as applicable
- Author protocols and technical documents and provide summary reports from LIMS
Skills and Requirements:
- Demonstrated success implementing LIMS and computer system validation in a cGMP environment
- Familiarity with data review for analytical methods such as Cell Based Assays, Flow Cytometry Assays, Microbiological assays, PCR and other routine analytical assays
- Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance
- General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
- Ability to communicate complex scientific findings and recommendations in one-on-one discussions and departmental meetings
- Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs
- Ability to work independently and as part of a team with internal and external teams
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
- Excellent skills in Microsoft Office, data analysis software, and other related applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.