Title: Process Development Associate Duration : 6 months Location: San Diego, CA 92121 Hours: 6:30 am to 3:00 pm
Job Summary: • Responsible for commercial manufacturing and for the creation and transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes.
Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. • Maintains the Pilot Plant laboratory under cGMP conditions. • Produces development, pilot and production materials per written instructions. • Completes ERP transactions. • Stocks and maintains the laboratory supplies. • Keeps accurate records and documentation. • Completes laboratory work and associated paperwork by assigned completion dates. • Produces notebook materials per written instructions. • Troubleshoots manufacturing process problems. • Develops manufacturing processes for transfer to Manufacturing. • Assists with execution of process validation of new and existing manufacturing processes. • Trains others on manufacturing tasks. • Improves manufacturing processes. • Completes cycle counts. • Washes lab ware.
Physical Demands The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. • Sit; use hands to finger, handle or feel objects, tools, or controls. • Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. • Lifting/moving and carrying products weighing up to 40 pounds. • Exposure to moving mechanical parts, vibration and/or moderate noise levels. • Exposure to hazardous chemicals or other materials. • Safety Shoes with Impact and Compression Protection Must be worn (will be provided). • Exposure to blood (serum).
Education: • Bachelor’s degree Experience • 1+ years’ experience preferred Skills Basic knowledge of QSM/GMP requirements Must follow all applicable FDA regulations and ISO requirements.
CPRA: The Company 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.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
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. At SPECTRAFORCE, 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: $25.00/hr.
