Quality Assurance Specialist

JOB DESCRIPTION Company: PBS Biotech Department: Quality Position/Title: Quality Specialist Location: Camarillo, CA 93012 Reporting To: Senior Manager, Quality Assurance FLSA Status: Compensation Range: Exempt $86k - $95k - $105k GENERAL PURPOSE This Quality Specialist is responsible for owning and investigating nonconformances and product complaints associated with PBS product and processes.
In addition to nonconformances and complaints, this individual may also be required to own/manage CAPAs and Change Records and serve as a QMS process owner.
This role supports production activities related to process/product improvement of bioreactors and single-use products manufactured by PBS.
Knowledge and experience with nonconformances, complaints, corrective and preventive actions, product impact assessment, root cause analysis and associated tools is required.
Additional leadership and project assignments will be assigned based on the needs of the business.
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 Owner for Complaint and Nonconformance investigations and maintenance of associated logs and metrics Owner for CAPAs and Change Records related to complaint and nonconformance investigations Liaise between the Engineering, Customer Service, Applications Engineering, and Quality departments to ensure investigations are completed in a timely manner Partner with colleagues in Engineering, Manufacturing, and Supply Chain to execute root cause analysis and drive continuous improvement through corrective actions.
Serve as subject matter expert for nonconformance, complaint, CAPA, and root cause analysis processes and provide guidance to colleagues on best practices Execute assigned tasks in support of CAPA implementation Maintain and revise quality system documents, such as SOPs, manuals, work instructions, manufacturing procedures, etc.
Responsible for continuous improvement of assigned processes May be assigned to perform QA approvals of quality records, and other tasks as needed May be assigned additional tasks and projects as needed to meet business objectives 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 Minimum 3 years in a Quality role or 5 years in a related role.
Minimum 3 years of experience working in a quality system with products regulated by GMP/Biopharma (21 CFR 210/211, ICH Q7/10) or medical device (ISO 13485, ISO9001:2015), or similar medical products field.
Advanced skills with MS Office applications Word, Excel, Powerpoint, etc.
Experience interfacing with peers in other departments to perform root cause investigations, write technical reports, and perform data analysis Excellent verbal and written communication skills including excellent technical writing skills.
Must be comfortable presenting to senior leadership.
A bachelor’s degree in a life science discipline or related science field with 3 years of relevant industry experience.
Preferred Education & Experience Bachelor’s degree or higher in a life science discipline Experience with a quality management system in drug/biotech/pharma (21CFR210/211), medical devices (21 CFR 820, ISO 13485/14971) or medical products (ISO 9001, ISO 13485).
Experience with ownership of quality records such as nonconformances, complaints, corrective actions, etc.
Experience using root cause analysis tools such as 5 Whys, Fishbone, DMAIC, FMEA, etc.
Experience with Veeva eQMS a plus 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; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing and test equipment.
May occasionally required to lift various weights up to 50lbs 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.
This role is primarily office work with some tasks or evaluation performed in a production or lab-like environment.
May be required to perform some tasks in the following environments: clean room; near moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant.
This position may be a combination of on-site and remote work in alignment with company flexible work environment policies.
NXTThing RPO is an Equal Opportunity Employer.
Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
68pwt9dpaH