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Manufacturing Operations Associate, Seal Beach, CAJob 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: ManufacturingSchedule / Shift: 3rd shift, 3x12 8:00PM-8:30AM (OT paid after 8th hour each day)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 (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) 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.
For immediate consideration, apply today! Questions? Call Jason at 714.971.0721 or email at jason.ines@kellyscientific.comWhy Kelly ® ?With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 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 career—connect with us today.AboutKelly Services ®As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook at https://www.facebook.com/kellyservices , LinkedIn at http://www.linkedin.com/company/kellyservices and Twitter at https://twitter.com/kellyservices .Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Vacancy expired!