Operation Specialist

Job Title: Operation SpecialistLocation: USA, CA-WoodlandDuration: 06 MonthsJob Description:Interview Process: One Round Onsite Interview with Hiring PanelPlease note: If candidate selected by 12/5/25, training is targeted to be conducted 12/22/25 - 12/24/25. Woodland site is going to be closed for the holidays 12/25/25 - 1/2/26. As such, the assignment training period would continue on 1/5/26.Scope of Position:Ensure that documented practices meet the true interpretation of the Serum CoE Quality Management System. Complete day-to-day manufacturing tasks which include manufacturing products in a clean room environment.Day to Day Responsibilities:• Support Serum CoE Quality Systems by creating, maintaining, and executing Quality Systems incompliance with ISO 13485 and FDA 21 CFR 820.• Compile and organize all quality related documentation and ensure all documents are filed in amanner that allows for easy access for regulatory and customer audits.• Issuing of labels and batch record documentation for all products.• May assist with writing of new and revising existing MMRs and QOPs to ensure procedures areaccurate, up to date, and are in compliance with current Good Manufacturing Practices and ISO13485.• Ensures all scheduled products are manufactured according to company procedures and cGMP's to achieve customer satisfaction and conformance to company schedule/deadlines• Understands the concepts of aseptic technique to operate inside Class 1,000 and Class 100 cleanroom areas as well as other controlled areas• Performs quality inspections on incoming and outgoing materials and products• Sorts and places materials or items on racks, shelves, or bins according to predetermined inventory proceduresneeded• Completes batch records in an accurate and timely manner following each days' production• Formulates, finishes, manufactures and fills all products produced at the plant with minimal guidance• Monitors equipment and completes basic equipment maintenance and cleaning activities• Utilizes and records readings from laboratory and manufacturing equipment• Closely follows work instructions provided in writing or verbally by supervisor/plant leadership• Moves stacks of crates from freezer to packaging area with hand truck/dolly to complete work• Inspects and packages product by checking for damaged bottles, labels and/or heat shrinks that do not meet established standards• Labels, bags, boxes and palletizes finished product in accordance with plant deadlines• Provide input to new, and revising existing, SOP's to ensure procedures are accurate, up to date and in compliance with current Good Manufacturing Practices• Responsible for reporting quality and safety issues to immediate supervisor• Ensures personal training documentation is up to date and aid in the training of others as needed• Maintain organization and cleanliness of production areas• Special assignments and other responsibilities as requiredTravel Requirements:No TravelHours of work/work schedule/flextime:40 hours/week, Monday-FridayEducation:Minimum required: Associate degree and relevant experiencePreferred: 4-year Biology Degree or Chemistry degreeRequired Years and Area of Experience:1-3 years of experience in Production, Manufacturing, Engineering and/or QualityRequired Skills:• Ability to develop, update and train on SOPs.• Working knowledge of ISO standards and cGMP.• Knowledge of computer programs, such as Word, Excel, PowerPoint, etc.• Good organizational skills; strong time management skills.• Strong interpersonal and communication skills.• High attention to detail.Preferred Skills:• Experience in a medical, pharmaceutical or biotechnology environment preferred.• SAP and/or PeopleSoft experience preferred. #TB_EN#ZRCompany DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA

Salary : $50