Manufacturing Technician

Integrated Resources Inc.; San Dimas (CA); On-site; Full time

Job summary

A premier staffing firm is seeking a Manufacturing Associate for its San Dimas location. The role requires expertise in aseptic processing and Good Manufacturing Practices (GMP). Ideal candidates bring 5+ years of experience and good communication skills. Responsibilities include operating manufacturing equipment and maintaining compliance with SOPs in a cleanroom environment.

Qualifications

• 5+ years of experience in a cGMP industry is required.
• Ability to work 12-hour shifts, including weekends and holidays.
• Must be able to operate and qualify for respirator use.

Responsibilities

• Perform moderately complex tasks associated with aseptic processing.
• Reports to Team Lead on line performance and issues.
• Assemble, disassemble, and operate aseptic filling equipment.

Skills

Knowledge of current Good Manufacturing Practices (GMPs)

Good verbal, written, and interpersonal communication skills

Demonstrates independent action and initiative

Strong safety orientation

Ability to operate a forklift or powered industrial truck

Ability to change into Gilead gowns

Education

HS Diploma

FETAC level 6 certificate

5+ years of relevant experience

Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-state area's most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy, and Nursing.

Job Description

Duration: 06 Months

Description:

• Works on basic to routine assignments following established Standard Operating Procedures (SOPs), Master Batch Records, and current Good Manufacturing Practices (cGMPs). Performs moderately complex tasks associated with aseptic processing, dispensing, compaction, granulation, milling, and coating.
• Reports to Team Lead regularly on line performance and reports any issues that need resolution.
• Works on more complex manufacturing processes and assignments.
• Assembles, disassembles, and operates aseptic filling equipment and lyophilizer autoloading equipment in classified cleanroom environments.
• Prepares equipment and components for sterilization.
• Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnels.
• Cleans (manually and clean-in-place) and assembles equipment for production. Performs clean-in-place and sterilization-in-place of tanks.
• Performs annealing and sterile filtrations of products.
• Operates vial cappers, unloads products from lyophilizers, and packs off unloaded vials from lyophilizers and liquid fill lines.
• Performs detailed Oracle (computerized software) and MES transactions in resolving inventory discrepancies.
• Cleans manufacturing areas, including walls, ceilings, and floors.
• Creates purchase orders for consumables.
• Completes and maintains documentation related to assigned work, including logbooks and batch records.
• May act as a point of contact for a compliance audit.
• Operates drum coater and compression equipment.
• Dispenses ingredients for batches.
• Performs MBR manufacturing batch report updates.
• Performs manual handling of product loads and unloads tablets.

Qualifications

Knowledge, Experience, and Skills:

• Knowledge of current Good Manufacturing Practices (GMPs).
• Good verbal, written, and interpersonal communication skills.
• Receives general instructions on routine work, and detailed instructions on new assignments.
• Follows written SOPs and Master Batch Records, able to take variant action only with management approval.
• Demonstrates independent action and initiative in resolving issues.
• Previous experience operating a forklift or powered industrial truck.
• Strong safety orientation, with strict adherence to safety practices and standards.
• 5+ years of relevant experience, HS Diploma, and a FETAC level 6 certificate.
• Prior experience in a cGMP industry is required.
• Ability to work on a rotational shift schedule, including day and grave shifts.
• Ability to work 12-hour shifts, weekends, and holidays.
• Must be able to operate and qualify for respirator use.
• Ability to see and distinguish all colors and shades.
• Ability to stand for at least 4 hours continuously.
• Ability to change into Gilead gowns and work attire as required.
• Occasionally lift 50 lbs; routinely lift 25 lbs.

Additional Information

Kind Regards,

Clinical Recruiter

Integrated Resources, Inc.

Gold Seal JCAHO Certified for Health Care Staffing

"INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)