Job Description

Manufacturing Associate

3 Months (Extendable)

Thousand Oaks, CA

Max PR: $30/hr

The starting shift is Wednesday through Saturday, 6:00 AM to 5:00 PM.

Role will transition between day shift and swing shift (job seekers must be flexible!!!)

Other shift time are Sunday-Wednesday (6am-5pm) or (1 pm-12 am) OR

start on days then transitioning to evening. Wednesday-Saturday (6am-5pm) or (1 pm-12 am)

PPE to be provided by Company.

The ideal candidate will have relevant biotech lab experience, particularly in areas such as quality control, with a strong understanding of safety protocols and Good Manufacturing Practices (GMP). Candidates with Lab experience, especially in areas like quality control (e.g., Quest Labs) or COVID testing, is great as it showcases their familiarity with safety protocols, PPE, and GMP skills.

Candidates who are flexible with their schedules, including the ability to work weekends and holidays. Strong communication skills, a positive attitude, and the ability to work effectively in a team are essential. Additionally, candidates should be mindful of their commute distance to ensure punctuality and reliability. Candidates who are adaptable, proactive, and have a positive approach to working with authority and leadership.

INTAKE NOTES:

Basic Qualifications

• High school/GED + 2 years work experience OR? Associate’s and 6 months work experience OR? Bachelors

Why is the Position Open?

• Supplement additional workload on team

Top 3 Must Have Skill Sets:

• Onsite, 4 days a week
• Can be on feet for long hours
• Repetitive tasks

Day to Day Responsibilities:

• Hands-on operations, set-up, clean, sanitize and prepare media and buffers per procedures
• Perform and monitor critical processes
• Execute routine validation protocols
• Comply with GMP's· Regularly draft and revise "routine" documents (e .g. MPs, SOP's, and technical reports)
• Initiate Quality incident
• Identify and recommend improvements related to routine functions and implement after approval
• Basic troubleshooting
• Recognize & accurately report problems
• Direct operators on critical processes
• Assist in the review of documentation for assigned functions (e.g. equipment logs, routine area audits, batch records)
• May train staff to perform hands-on tasks
• May act as safety representative
• May assist with system ownership responsibilities
• Staff member was be able to transfer equipment via push carts or round floor dollies into the processing suites
• Staff member must be able to collect and conduct inline process testing of pH, conductivity, LAL
• Staff member must be able to operate lab equipment.
• Staff member must be able to interface with computers to revise documents, draft investigation, training, log samples, projects.
• Staff member must be able to sanitize equipment/materials via spray bottles and wipes.
• Staff member must be able to lift and carry 10kg weight for scale verifications.

Possible Extension:

• Yes

Red Flags:

• poor communication
• not flexible or adverse to working holiday or OT or any shift.
• Long commute.

Summary

• The Associate of Manufacturing will work in a dynamic production environment at the Company Thousand Oaks Site supporting development, clinical, and launch activities. Under general supervision, employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).

Responsibilities include:

• Hands-on operations: set-up, cleaning, and sanitization of various manufacturing equipment
• Preparing buffers/media per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
• Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
• Performing and monitoring critical processes with the ability to perform basic troubleshooting
• Performing in-process sampling of equipment and operating analytical equipment
• Performing washroom activities: clean small and large scale equipment used in production activities
• Maintaining an organized and clean workspace
• Working in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work
• Initiating quality reports? Drafting and revising documents (SOPs, MPs)
• Identifying, recommending, and implementing improvements related to routine functions
• Assisting in the review of documentation for assigned functions (equipment logs, batch records)
• Performing activities that include periods of rigorous, repetitive work
• Working around high-pressure systems and occasionally work around heavy equipment

Qualifications

• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs, 3 or 4x12hrs) as dictated by the production schedule
• Able to work in teams to complete operational tasks
• Able to take direction well, follow documents and policies at all times
• Able to take initiative
• Creates positive work environment through interactions with team members
• Able to regularly lift up to 35lbs, push and pull objects that require up to 50lbs of force, and work on your feet for long durations.
• Able to perform the list of physical movements that may be necessary to perform daily functions on the production floor: bending, reaching above the head, climbing, kneeling, squatting, stooping, walking upstairs, and standing on portable stairs or ladders up to 6 feet off of the ground.

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