Fremont, CA | Contract
Bayside Solutions is seeking a Manufacturing Associate to be a part of our partner’ s team in the San Francisco East Bay Area. This is an opportunity to work with a Biotechnology company focused on providing fast acting therapeutic relief through a proprietary transdermal system.
Our partner’ s culture is fosters creativity, execution, accountability, urgency, and transparency. These are aspects of that are essential for establishing a robust portfolio of products that they have in development.
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 biotech utilizing current drugs for their fast acting transdermal applications
- 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:
- Support manufacturing set-up, operation, troubleshooting and dismantling equipment used for the preparation of drug delivery systems.
- Provide support for process and equipment validation activities for cGMP operations.
- Demonstrate ability to recognize and document equipment malfunctions and process deviations.
- Assist with resolving technical issues as well as maintenance of production equipment.
- Follow SOPs and complete master production records in a cGMP environment.
- Complete and Review batch production records to ensure cGMP documentation practices are followed and information entered is complete and accurate.
- Provide communication between shifts to ensure smooth and efficient transition of tasks.
- Bring equipment and facilities issues to the attention of the Supervisor for resolution.
- BS with one years’ experience or equivalent years’ experience the medical device field or Pharmaceutical/Biotech industry.
- Aseptic manufacturing experience is highly desired.
- Experience with gowning up procedures and protocols.
- Experience in classified clean room manufacturing operations is required.
- Perform duties in accordance with Current Good Manufacturing Practices (cGMP’ s), FDA and ISO guidelines.
- Strong mechanical aptitude and familiarity or experience in handling drug compounds, organic chemicals and solvents is required.
- Must be open to 1st shift (7: 00AM) and 2nd shifts (2: 00PM) start times.
- Demonstrated basic math skills.
- Able to sit or stand for long periods of time.
- The ability to lift 35-40 lbs. is essential.