Manufacturing Associate I-Assembly & Packaging/ GMP Assembler

Location: Fremont
Posted on: June 23, 2025

Job Description:

Job Title: Manufacturing Associate I-Assembly & Packaging Location: Fremont, CA 94555 Duration: 6 Months Schedule Notes: 1st Shift: Mon-Fri, 6:00AM-2:30PM Note: This position will require individuals to be fully vaccinated against COVID-19 or have an approved medical or religious accommodation. Duties : Executes routine unit operations in Manufacturing Assembly and Packaging as assigned related to the manufacturing of drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. This position is responsible for assisting the Sr. Associate and Master Associate in performing assembly and packaging in designated functional manufacturing area. Support with troubleshooting to equipment. Duties & Responsibilities: Assists in the setup of the automated autoinjector assembly machine, pre-filled syringe assembly machine and semi-automated tabletop machine. This assistance includes tasks such as gathering tools, machine parts and documents required for such activities. Retrieves components and equipment from storage Assists with the equipment changeover Assists with minor equipment repairs/adjustments Assists 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 logbooks, 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 Movement of product and components within the assembly and packaging area Transfer product, components and equipment within the CNC area. Communication and hand-off to relief personnel during shift change as appropriate Maintains production areas according to predefined standards (5s) Adheres to safety standards, identifies unsafe situation / habit and escalates appropriately Skills : Demonstrated ability to be organized and work well in small work groups. 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. Works regularly under desirable conditions with some moderately disagreeable conditions in the manufacturing setting 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. Education : High School degree plus minimum one (1) year work experience in GMP regulated industry Associate/Bachelor’s degree from an accredited institution or biotechnology vocational training preferred About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions. Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law. Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com . LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. At SPECTRA FORCE , we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $20.00/hr.

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