Manufacturing Associate II
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a Manufacturing Associate II to be part of our client’ s team in the Fremont area. 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 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.
Manufacturing Associate 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:
- This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly packaging in designated manufacturing area.
- Specific to the Assembly and Packaging area, this includes, but is not limited to:
- Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine.
- Movement of product and components within the assembly and packaging area.
- Transfers product, components and equipment within the CNC area.
- Assists with the equipment changeover.
- Assists with minor equipment repairs/adjustments.
- Assists in the identification & correction of problems to prevent down-time.
- Communication and hand-off to relief personnel during shift change as appropriate
- Assists in the assembly and packaging operation.
- Assists the Sr. Associate and / or Master Associate with assembly and packaging set up. This assistance includes tasks such as gathering tools, machine parts, and documents required for such activities. Retrieves components and equipment from storage.
- Assists the Sr. and Master Associate with real-time identification and correction of problems. Problems may include, but are not limited to mechanical issues, component issues.
- Performs all work in accordance with Company Policies and Procedures. All work is documented in controlled documents (batch records, logbooks or SOP attachments) in accordance with SOP. All activities are to be documented in the batch record. All events are to be recorded in the batch record and brought to the attention of the production supervisor for further action.
- Assists with room cleaning in production areas. Will transfer rubbish to the transfer zones and may empty transfer zones of rubbish when required. This includes removal of equipment, room sanitization and disposal of waste according to established safety requirements.
- Responsible for following controlled documents to ensure that the equipment identified for operations are used and documented. This includes verification of equipment calibration. Completes log books, as required.
- Responsible for performing assembly and packaging operations and assisting in visual inspection/filling operations, if required.
- Ensures components, materials and supplies are stocked prior to the start of the assembly and packaging operations.
Summary of Qualifications:
- Bachelors’ degree, preferably in a science or engineering field. In lieu of a Bachelor' s degree, will consider a minimum of three years closely related experience in a GMP or clean room assembly environment with an Associate’ s Degree. Or 6 years closely related experience in a GMP or clean room assembly environment with a High School Diploma or equivalent.
- 1+ years of experience in a biotech manufacturing environment or other regulated cGMP manufacturing facility and a Bachelor’ s degree in science related area or engineering or Associate’ s degree in science related area or Biotech certificate or in lieu of Education requirements 3 years of experience in cGMP manufacturing environment.
- Demonstrated ability to be organized and work well in small work groups.
- Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians.
- Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions.
- Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions.
- Demonstrated written and verbal communication skills are required
- Must be able to work in a team environment.
- Experiences in related GMP environment within biotechnology/pharmaceutical industry strongly preferred.
- Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software.
- Physical Demands / Surroundings - Requires physical activity such as almost constant standing, walking, eyestrain, working with hands inside an Isolator, etc. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting.
- Visual Demands - Position requires constant use of computer terminals and routine / repetitive work.
- Temperaments/Mental Requirements - The position requires concentration as errors might cause minor to moderate delays, confusion, or expense to correct. The position has some contact with other departments and the associate must be able to discuss issues and ideas with an open mind and even temper.
- Level of Proficiency - Entry level in subject matter.
- Attendance / Schedule- The schedule is dependent on the shift for which the associate is hired. Attendance requirements are based on general attendance policies.
- To remain in this position, employees:
- Must obtain & maintain qualifications, as required, to perform the assigned work.
- Must understand, will be held accountable for and must adhere to all SOPs, company Policies and Procedures.
- Must adhere to proper technique, proper documentation practices, and all other aspects of the cGMP’ s.
- Must maintain all training requirements and regularly checks the LOS training system in order to complete all required training on time.