GxP Application Specialist
300 Bel Marin Keys Boulevard Novato, CA 94949
Bayside Solutions is seeking a GxP Application Specialist to be part of our client’ s team in Novato. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
GxP Application Specialist
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- The GxP Application Specialist will implement Instrument based software (COTS) in the Quality Control labs.
- The Application Specialist is a hands on, individual contributor that will help ensure that systems are implemented efficiently (following a standard process) so that the lab can maintain a high standard of efficiency and compliance with current data Integrity requirements.
- Coordinate projects and manage deliverables across multiple departments (QA, QC, IT etc.).
- Research software functionality for COTS systems to determine suitability and capability of meeting user requirements.
- Configure software using the standard ‘ out of the box’ interface.
- Draft SDLC documents including FRS, UAT and Test Cases.
- Provide content for ' end user' SOPs, work instructions and training materials.
- Document, and communicate project outcomes (Positive/Negative) to management and participate in efforts to improve the process.
- Assist in ad-hoc projects as needed to address QC Informatics deviation investigations or initiatives.
- Perform Post-Go live application support.
Summary of Qualifications:
- Minimum: BA/BS degree OR six years direct experience in a similar role
- Additional Desired: PMI and/or ASQ (CSQE) certification
- Must Have:
- Minimum 1 year of Systems Analysis experience, including troubleshooting and root cause analysis
- 3 years in a Pharmaceutical/Biotech environment preferably with either lab experience or software implementation experience.
- Microsoft Office (or similar) application skills.
- Project coordination experience and organization skills.
- Positive communication skills (written and verbal), including lateral management, meeting management, and negotiation skills.
- Highly Desired Experience:
- Common software solutions used in the QC lab (SoftMax Pro, Empower, LIMS, ELN, etc)
- Standard software development methodologies (Agile, Waterfall, etc.)
- 21CFR Part 11, GAMP, ALCOA+