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13 days old

Aseptic Manufacturing Operations Associate - 3rd shift, Seal Beach, CA

Kelly Services
Seal Beach, CA 90740
**Manufacturing Operations Associate, Seal Beach, CA**



**Job Summary:** Aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room environment (Class 10,000/ISO7, and Class 100,000/ISO8).



**Functional Area:** Manufacturing



**Job Duties and Responsibilities:**




+ Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.

+ Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.

+ Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.

+ Represents department in cross-functional teams, projects and GXP-related problem resolution.

+ Posts weights and shipping charges, and prepares goods for final shipment.

+ Prepares and maintains records of merchandise shipped.

+ Prepares goods for final shipment and unpacks and checks goods received against purchase orders and invoices, maintains records of received goods, rejecting unsatisfactory items if necessary.

+ Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.

+ Other duties as assigned



**Scope:**




+ Applies job skills and company policies and procedures to complete a wide range of tasks.

+ Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.

+ Normally receives general instructions on routine work, detailed instructions on new assignments.

+ Uses ability as a skilled specialist in accordance with company policies and procedures to compete complex tasks in creative and effective ways.

+ Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making routine recommendations.

+ May determine methods and procedures on new assignments and may provide guidance to other support personnel.

+ Ability to be flexible and support all functions by readily responding to changing circumstances (i.e shift changes) and business needs.



**Job Requirements:**




+ Associate's degree (AA / AS) or Medical Technical degree or equivalent.

+ Typically 2 years related experience in CGMP / FDA regulated industry or 1 year with Medical Technical degree.

+ Proficient in MS Office applications.



**Working Conditions:**




+ Ability to sit or stand for extended periods of time

+ Intermittent walking to gain access to work areas

+ Finger dexterity sufficient to use a computer and to complete paperwork activities

+ Vision sufficient to use a computer, to read written materials and to complete paperwork activities;

+ Hearing sufficient to communicate with individuals by telephone and in person

+ Ability to lift up to 25 pounds. Limited exposure to (2C - 8C); (-20C); (-75C); (-196C) areas.

+ Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 - 20 lbs and lift up to 50 lbs.

+ May be required to work alternate shifts

+ Ability to gown aseptically for work in Clean Room environments

+ Job performed in a lab, office, or utility (noisy) environment

+ Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.



Apply today! Question? Email jason.ines@kellyscientific.com






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-29 Expires: 2019-12-30

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Aseptic Manufacturing Operations Associate - 3rd shift, Seal Beach, CA

Kelly Services
Seal Beach, CA 90740

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