6701 Kaiser Drive
Industry: Clinical & Scientific
Job Number: 16023
Bayside Solutions is seeking a Compliance Specialist to be part of our client’ s team in the East Bay. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
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.
- 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:
- Individual contributor role responsible to manage investigations, own change control records and lead projects in support of manufacturing.
- This person will support in the planning, monitoring, reporting of deviations, CAPAs, Change Controls and improvement projects.
- Manages small to medium / simple to moderately complex deviation events using root cause analysis techniques.
- Utilizes clear writing strategies to ensure content is clear, concise and complete.
- Bachelors’ degree in science or engineering related field is beneficial, but not required.
- Associates degree with 5 years of experience or High School Diploma with 6 years’ experience in cGMP Biopharmaceutical manufacturing, with positions of progressive responsibility are required.
- Possesses knowledge in the area of manufacturing Biopharmaceuticals. Has experience in managing simple to moderate projects, deviation investigations and CAPAs.
- Possesses knowledge of cGMP systems and of regulatory requirements from different regional jurisdictions.
- Experience leading and facilitating meetings, has experience writing technically - SOPs, Protocols, Deviation Reports, etc.
- Must be able to multi-task - will work on several records simultaneously.
- Must have a composure around management- demonstrated confidence speaking to Sr. Management.