GxP Application Specialist
105 Digital Drive Novato, CA 94949 | Contract
Bayside Solutions is seeking a GxP Application Specialist to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.
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. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.
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
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.
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
- 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.
- Minimum: BA/BS degree OR six years direct experience in a similar role
- Additional Desired: PMI and/or ASQ (CSQE) certification
- Project coordination experience and organization skills.
- 3 years in a Pharmaceutical/Biotech environment preferably with either lab experience or software implementation experience
- Positive communication skills (written and verbal), including lateral management, meeting management, and negotiation skills.
- Microsoft Office (or similar) application skills
- Minimum 1 year of Systems Analysis experience, including troubleshooting and root cause analysis
- 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+