Works independently under close superv7ision, qualify and validate equipment, instruments, and systems. Develop validation plans, protocols, and testing specifications. Analyze validation reports and make recommendations for changes and/or improvements. Assist in the selection of equipment and systems and negotiate competitive pricing. Work with regulatory agencies on inspections. This position will be responsible for performing validation activities to optimize quality assurance (QA) testing processes. This is a hand-on position working cross functionally with Production, Quality, and Technology & Innovation groups to effectively document testing capability.
location: Carpinteria, California
job type: Permanent
salary: $70,000 - 73,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
- Consult with associates and supervisors as to specific safety, chemical, or handling concerns.
- Perform test method validation activities, including receiving and/or providing training, procuring materials and supplies, performing testing, and documenting results.
- Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical disciplines.
- Assist in provide technical decision-making regarding validation strategies and requirements.
- Contribute to the creation of Standard Operating Procedures and training materials.
- Author and approve basic validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes.
- Perform and coordinate and manage instrument/equipment qualification testing.
- Help to coordinate the DQ, IQ, OQ, PQ and PV of all validation activities to assure compliance with customer requirements, ISO 9001 / ISO 13485, 21 CFR 210 & 211and 21CFR 820.
- Identify any areas for improvement and propose and / implement approved necessary changes.
- Prepares, writes and reviews basic validation protocols and documentation to ensure compliance and adherence to AMRESCO's SOP's, Customer specifications, ISO9001, ISO 13485, 21 CFR 210 & 211, 21CFR 820 and other applicable regulations. This includes regulatory bodies in the US and International.
- Maintains all Validations and assures they are updated as required. Periodic review is established based on a data review of quality inputs and outputs to assure outcome is as expected.
- Consult with associates and supervisors as to specific safety, chemical, or handling concerns.
- Assists in reviewing need for validation with design group for all processes, equipment and , methods. etc.
- Support QA department as needed.
- Performs other duties as assigned.
qualifications:
- Bachelor's degree in Engineering, Material Science or Life Science (Chemistry, Biology, Physics, etc.); work experience may be considered in lieu of degree
- 1-3 years applicable experience
- Excellent communications skills, both oral and written.
- Excellent analytical, statistical, and strategic thinking skills.
- Strong knowledge and skill in the use of MS Office suite; experience with statistical software products (Minitab, SAS, etc.) is preferred.
- Must be proactive and independent in daily operation.
- Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation, CFRs and their application to Medical Devices or Biopharma
- Knowledge of statistical data analysis, word processing, flow charting, and project management
- Familiarity and understanding of manufacturing methods related to the production of medical devices and related products
- Familiarity and understanding of technical disciplines related to Quality Control and Quality Assurance, including Engineering and process controls
- Good communication skills, both verbal and written
- Ability to work independently and as a team member, as well as, with Consultants/Contractors to achieve projects' validation objectives
- Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.
- Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
- A frequent volume of work and deadlines impose strain on routine basis.
- Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.
- Although the associate primarily works in an office environment, while performing the duties of this job, the associate is exposed to a production environment. The associate may work near moving mechanical machinery and/or vehicles and the noise level in the work environment can be loud. While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.
skills: Quality control, Biology, Chemistry, Biomedical Engineering
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
