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Location

Camarillo, CA | United States

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Job description

Company:	PBS Biotech, Inc
Department:	Quality
Position/Title:	QA/QC Associate
Location:	Camarillo, CA
Reporting To:	QA Senior Manager
FLSA Status:	Non-Exempt
Salary Range:	$26.88 - $34.95 Hourly

This role will train on 1 st shift and will transition to working 2nd shift - 2:00pm - 10:30pm.

 

GENERAL PURPOSE

PBS is seeking a QA/QC Associate to support 2nd shift operations related to the production of PBS bioreactors.  This position performs Quality Control (“QC”) inspections of incoming materials, components, and in-process products, and will also perform some Quality Assurance (“QA”) functions, such as managing and approving deviation reports (nonconformances), batch record (work order/router) documentation.  This role requires experience working in a controlled environment (Clean Room), performing QC and QA functions, compliance to specifications, procedures, and good documentation practices, according to FDA regulations for GMP and ISO 9001:2015. The ideal candidate will have experience with FDA GMP regulated products, i.e., medical device, biotech, or pharmaceutical.

 

Responsibilities

Essential functions of the job are listed below.  Other responsibilities may also be assigned.  Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Primary Responsibilities

• Perform inspections for assembled products per procedures and complete related documentation and approvals. Perform sampling and inspection of incoming materials and components per procedures, specification documents, statistical sample plan (e.g., AQL), using inspection tools such as micrometers, calipers, height gages, and visual inspection.     
• Manage batch documentation (work orders and routers) including initiation, review, approval, and filing.
• Review and provide Quality approval for various documents including component specifications, inspection procedures, and standard operating procedures.
• Perform or support management of QA records such as nonconformance reports, supplier corrective actions, work orders, internal audits, and CAPAs.
• Perform or support Environmental Monitoring program in accordance with ISO 14644 standard.
• Additional QA tasks and duties may be assigned based on capability and business need.

 

 

Minimum Qualifications

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position.  Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

 

Knowledge/ Experience

• Associate or bachelor’s degree preferably in Life Sciences or other science-based area, or at least 7 years of skills and experience that provides equivalent knowledge.
• Minimum 3 years of experience performing QC Inspection, or 5 years of combined experience in a related role such as analytical lab testing, validation test technician, or receiving/inspection operator.

 

Skills/ Abilities Pertinent to This Position

 

• Advanced skills with MS Office applications Word, Excel, as well as Adobe Acrobat.
• Excellent verbal communication and writing skills, including good documentation practice.
• Proven ability to follow procedures, complete assigned tasks, work with minimal supervision, and work in teams.

 

PHYSICAL DEMANDS

In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing equipment.  Must be able to lift various weights as needed to meet job requirements.

 

WORK ENVIRONMENT

In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

 

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Job tags

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Salary