QA Analyst II
22 DNA Way, SSF05 South San Francisco, CA 94080
Bayside Solutions is seeking a QA Analyst II to be part of our client’ s team in South San Francisco. 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.
QA 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:
- Create, revise, and review LIMS master data for IMP products.
- Provide maintenance and support for master data as required.
- Participate on interdepartmental/global teams, process improvements, or new system design.
- Ensure the smooth introduction of new, routine, and complex master data functionality of the software as they are added.
- Act as subject matter expert (SME) by demonstrating master data and software proficiency.
- Develop and maintain expert working knowledge of LIMS functionality through all software upgrades and project implementations.
- Provide technical expertise for LabWare LIMS projects, troubleshooting of system, and interfacing of data.
- Initiate or assess discrepancies associated with master data issues.
- Make informed decisions on master data issues in collaboration with key stakeholders and adhering to system requirements.
- Possess analytical and/or computer skills sufficient to: 1) Understand data requirements and interdependencies, 2) Solve problems through effective troubleshooting and suggest viable solutions, 3) Continuously improve systems achieving increased compliance and efficiencies.
- Translate business needs into user requirements for complex master data enhancements.
- Support IMP reference standard expiry extensions, including generation of trend charts and reports.
- Review and respond to problems, monitor issues and initiate resolutions.
- Accomplish corporate, operational, and departmental goals.
- Work with internal departments and outside vendors, collaborators and partners concerning projects and commitments.
- Be flexible and adapt to changing work priorities, as needed.
- Maintain an inspection-ready state, and support GMP audits.
- Collaborate with management to establish and meet targets and timelines
Summary of Qualifications:
- BS degree in Life Science or equivalent.
- At least 3-5 years of relevant experience in Quality Control, Quality Assurance or equivalent experience in the pharmaceutical/biotechnology industry.
- Experience with data management, in particular working knowledge of LIMS systems.
- Good understanding of GMP principles and regulations.
- Flexibility in problem solving to meet business objective.
- Ability to make sound decisions regarding scheduling and managing priorities.
- Ability to communicate clearly and professionally both in writing and verbally.
- Demonstrate interpersonal skills to work effectively with internal stakeholders, customers, contractors, and cross-functional project teams.