Job Description

Title: Operations Specialist- Quality & Manufacturing

Duration: 6 Months (Possibility of extension based on demand.)

Location: On-site at Woodland, CA

Travel Requirements - No Travel

Description:

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 in

compliance with ISO 13485 and FDA 21 CFR 820.

• Compile and organize all quality related documentation and ensure all documents are filed in a

manner 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 are

accurate, up to date, and are in compliance with current Good Manufacturing Practices and ISO

13485.

• 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 procedures

needed

• 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 required

Hours of work/work schedule/flextime:

40 hours/week, Monday-Friday

Education:

Minimum required: Associate degree and relevant experience

Preferred: 4-year Biology Degree or Chemistry degree

Required Years and Area of Experience:

1-3 years of experience in Production, Manufacturing, Engineering and/or Quality

Required 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.

Working Conditions:

Part time office environment, part time manufacturing environment. Frequently lifts and/or moves up to 25 pounds and up to 60 pounds occasionally; rarely lifts over 60 lbs. Use of noxious or hazardous chemicals with appropriate PPE. Protective clothing or equipment may occasionally be required including gloves, freezer jacket or jumpsuit, protective eyewear, footwear. May perform work in a clean room environment.

** Includes use of a respirator in this role.

Interview Process:

One Round Onsite Interview with Hiring Panel

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