Job Title: Cleanroom Production Operator

Job Description

Perform daily production and packaging activities in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs). Continually work to achieve assigned production goals; meet unscheduled peaks in workload as necessary to ensure timely release of product and to avoid back orders. Work with Team Leader and colleagues to detail critical raw materials, in-process procedures, and specifications. Address corrective action for technical problems related to raw materials and finished products. Perform in-process quality checks on sub-assemblies and finished products. Resolve line issues and other production problems; promptly notify Team Leader or appropriate personnel of required corrective action. Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs. Use computerized Materials Resource Planning (MRP) inventory system as required to report lot controlled ingredients on batch records.

Responsibilities

• Perform daily production and packaging activities in accordance with GMP and SOPs.

• Achieve assigned production goals and meet unscheduled peaks in workload.

• Work with Team Leader and colleagues to detail critical raw materials, in-process procedures, and specifications.

• Address corrective action for technical problems related to raw materials and finished products.

• Perform in-process quality checks on sub-assemblies and finished products.

• Resolve line issues and other production problems; notify Team Leader or appropriate personnel of required corrective action.

• Maintain accurate records and documentation in accordance with GDP and all related SOPs.

• Use MRP inventory system to report lot controlled ingredients on batch records.

Essential Skills

• Knowledge of cleanroom procedures.

• Understanding and application of GDP and SOPs.

• Ability to give detailed examples of SOP usage and GDP practices.

• Experience in machine operation, multitasking, quality assurance, packaging, and inspection.

• Familiarity with DHR and computer operation.

Additional Skills & Qualifications

• At least two years of previous assembly/packaging experience.

• Previous experience in a regulated medical device manufacturing or pharmaceutical environment preferred.

• Experience with coagulation-based manufacturing processes is a plus.

• Familiarity with GDP, GMP, GLP, FDA, and ISO.

• Knowledge of qualification and validation trials is a plus.

• Working knowledge of Microsoft Office and large ERP systems preferred.

Why Work Here?

The team invests in each employee. Contractors are also included in company quarterly events, typically a catering event in the parking lot with lunch and food provided.

Work Environment

Technical Operator 1 positions are for 1st shift, 3pm to 11:30pm. Dress code includes wearing pants (leggings not allowed), no makeup or lipstick, necklaces tucked into shirts, and side shields on glasses. The room can get loud, and ear protection will be provided. Headphones and cell phones are not allowed on the manufacturing floor. Overtime may be required after training, with some voluntary and some mandatory. Reliability is crucial as the process depends on every team member. Pay raises are available upon conversion, and opportunities exist to advance to Technical Operator 2 within 3 months. Knowledge of work orders, machine operation, and computer systems such as SAP is beneficial.

Job Type & Location

This is a Contract to Hire position based out of San Diego, California.

Pay and Benefits

The pay range for this position is $20.63 - $20.63

• Medical, dental & vision

• Critical Illness, Accident, and Hospital

• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

• Short and long-term disability

• Health Spending Account (HSA)

• Transportation benefits

• Employee Assistance Program

• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in San Diego,CA.

Application Deadline

This position will be accepting applications until Dec 31, 2024.

About Aerotek:

We know that finding work is hard, and finding meaningful work is harder. Aerotek connects 180,000+ light industrial and skilled trades workers with 14,000+ employers each year, helping our workers navigate an evolving labor market and find jobs that meets their goals, skills and interests. Since 1983, we have provided a variety of career opportunities across North American industry – from short-term assignments at Fortune 500 companies where you can build your skills, to long-term opportunities where you can play a vital role solving for companies’ construction, manufacturing and maintenance challenges. Our 1,500+ experienced recruiters across 250+ offices work relentlessly to put our workforce in a position to thrive. Let us rise to meet your challenges and put our people-are everything spirit to the test as your career continues to grow.

Aerotek offers weekly pay, employee benefits including medical, dental & vision, life insurance, health advocacy and employee assistance programs, a 401(k) plan, and employee discounts.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.