Business Systems Analyst II
300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a Business Systems Analyst II to be part of our client’ s team in the North Bay. 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.
Business Systems Analyst II
- 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 Business Systems Analyst 2 in the Information Management department will provide application support and implement software that meets the User Requirements and long-term goals/strategy of the QC department. The Business Systems Analyst 2 will help ensure systems are implemented efficiently following a standard process so that the lab is delivered systems that enhance compliance, improve efficiency and reduce regulatory risk.
- Gather software specific requirements and draft SDLC documents
- Organize project meetings, and perform standard meeting organizer duties (agenda, minutes action items etc.)
- Research system/software functionality to determine suitability and its capability of meeting user requirements
- Drive the team towards improved technical solutions to ensure data integrity
- Configure software using standard out of the box tools and GUI to meet specific lab process requirements
- Communicate to System Owner and user how the software meets their requirements
- Assist in the development of Risk Assessments by providing software/system specific expertise
- Draft preliminary test cases for IQ/OQ/PQ protocols
- Draft SOPs, work instructions and other training materials
- Document, and communicate project outcomes (Positive/Negative) to management and participate in effort to constantly improve the process
- Assist in ad hoc projects as needed to address deviation investigations or initiatives.
- Mentor junior staff
- Educate System Owner regarding compliant software and business process choices that ensure data integrity is maintained
- Provide Post-Go live system/application support
Summary of Qualifications:
- Minimum: BA/BS degree in either Lifesciences (Microbiology, Biology, Biochem, Analytical Chemistry etc.) or Computer Science/MIS related degrees ~ Or a minimum of 8 years direct experience in a similar role with escalating levels of responsibility will be considered
- Highly Desired: ASQ, PMI, ITIL certifications
- Ability to plan and prioritize assignments effectively to meet timeline commitments
- A strong desire to implement solutions that solve pressing compliance and process problems
- 5 years in a regulated industry (preferably Pharmaceutical/Biotech, Medical Devices or Healthcare industries)
- Strong interpersonal communication skills including, formal presentations, meeting management, negotiation/persuasion and conflict resolution
- Self-motivation, and be a quick learner of business processes and technology
- Strong Microsoft Office (or similar) application skills including Word, Excel, PowerPoint, Visio, and Project
Highly Desired Qualifications:
- Experience implementing, or managing common software solutions used in the QC lab (Empower, SoftMax Pro, LIMS, ELN, LES, etc)
- Experience as a software business administrator
- 2 years bench level laboratory experience
- 4 years direct experience implementing/validating software in a regulated environment
- Experience as a Project Manager or Project coordinator
- Experience in generating SDLC deliverables particularly URS, FRS and Config Spec
- Experience/Knowledge of good requirements gathering techniques including process mapping techniques. (LEAN, SIX SIGMA)
- Experience in standard software development methodologies (Rapid, Waterfall, etc.)
- Experience initiating and managing Change Control, and Deviations requests with TrackWise