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Manufacturing Lead Technician - (Aseptic Filling) (Los Angeles)

Manufacturing Lead Technician - (Aseptic Filling) (Los Angeles)

GrifolsLos Angeles, CA, US
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Manufacturing Lead Technician - (Aseptic Filling)

Location : CA-Los Angeles, US

Contract Type : Regular Full-Time

Area : Manufacturing

Position Summary :

In general, the Manufacturing Lead Technician is responsible for overseeing the coordination and operations of the production schedule, shift, and personnel.

Essential Job Duties :

  • Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals.
  • Strict adherence to procedures and practices according to FDA regulations.
  • Strong emphasis on documentation according to FDA regulations.
  • Adhere to departmental corporate safety policies.
  • Responsible for facility and equipment cleaning.
  • All work is performed in a clean room (sanitized) manufacturing environment.
  • Responsible for basic process analysis such as pH, refractive index, turbidity, and conductivity measurements.
  • Operates manufacturing equipment such as ultrafiltration (UF) units, chromatography columns, Clean In Place (CIP) systems, Steam In Place (SIP) systems and centrifuges.
  • Utilizes touch screen Operator Interface Terminals (OIT).
  • Trains entry level personnel.
  • Performs more complex and advanced job tasks.
  • Assist management in coordinating and scheduling the department's day to day operations.
  • Serves in a leadership role in the absence of direct supervision.
  • Other duties may be assigned.

Required Experience / Skills & Educational Qualifications :

  • High school diploma or GED required. Associate's degree, applicable certification, and / or military veterans preferred.
  • Minimum of 3 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required.
  • Demonstrated leadership skills with the ability to motivate, guide, train, coach and develop department personnel.
  • Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
  • Ability to work independently with minimum supervision.
  • Must be proactive, results oriented, and have strong attention to detail.
  • Self-starter with strong work ethic and the ability to exercise good judgment.
  • Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
  • Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
  • Must be able to read, write, and speak English.
  • Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
  • Must be flexible with working hours / shifts in order to accommodate the 24-hour, 7 day plant operation.
  • Occupational Demands :

    Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Operate power equipment. Exposure to high levels of noise and to dust / gas / fumes / steam. Exposure to extreme cold below 32

  • and on occasion, exposure to extreme heat above 100
  • . Exposure to vibration or oscillating movements of the extremities or the whole body. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and / or on ladders. Walks on uneven ground. Personal protective equipment required such as : protective eyewear, face shields, chemical suits, safety shoes and / or rubber footwear, gloves, hearing protection and a respirator. Heavy lifting and carrying of 50lbs. for up to 6-8 hours per day, with a maximum lift of 75lbs. Work is performed standing, walking, bending and twisting waist for 4-6 hours per day. Frequent foot movements. Occasionally reaches above and below shoulder height. Occasionally bends and twists neck. Frequent hand movements with simple grasping of one hand with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Hearing acuity essential. Color perception / discrimination, depth perception and far vision correctable in one eye to 20 / 30 and to 20 / 100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs a wide range of complex tasks. Adheres to a work schedule to meet production standards.
  • The estimated pay scale for the Manufacturing Lead Technician role based in Los Angeles, CA, is $34.00-$35.00 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to : Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression.

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    Manufacturing Lead • Los Angeles, CA, US