Title: Quality Assurance Technician
Location: Van Nuys, CA
Duration: 06+ months (possible extension)
- Plan, develop, lead and evaluate improvement and compliance projects related to receiving and inspection operations, in a timely and cost-effective manner.
- Responsible for basic project management and documentation authoring (e.g. protocols, reports).
- Self-led individual that works under only very general supervision to meet deadlines and goals.
- Ensure projects are implemented within stated goals, timelines and budget tolerances.
- Use project management tools to develop mechanisms for monitoring project progress.
- Be directly involved in and lead multiple process/product improvement projects. These projects may be executed through CAPA, change controls, QWTs, etc.
- Responsible for document revisions to procedures, forms and specifications as needed.
- Write memos, reports, protocols and other appropriate documentation as they pertain to receiving and inspection operations and procedures.
- Initiate and own change controls impacting QARI, as well as support change controls impacting the department, as assigned.
- Support execution of validations for equipment, lab methods or facility projects.
- Administer and maintain relevant databases, preparing and issuing reports as defined by the area as well as developing custom reports as needed.
- Be able to support departmental / plant goals.
- Be able to work independently and with general supervision.
- Must be self-motivated and have strong interpersonal skills.
- Ability to operate in a dynamic, cross-functional environment.
- Be able to have great attention to details is necessary.
- Be able to handle multiple tasks concurrently.
- Have strong organizational skills and the ability to follow-up tasks Have good critical thinking and problem-solving skills.
- Have excellent verbal and written communication skills.
- Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and US standards of measurement.
- Have general computer knowledge.
- Have general knowledge of biotech manufacturing theories and processes.
- Ability to design and implement projects/studies outside area of expertise.
- Have knowledge of Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and application of current Good Manufacturing Practices (cGMP).
- Bachelor’s degree in science, engineering, or other related technical field required and at least two years of project management experience preferred.
- Familiar with cGMP and FDA requirements.
- Must be able to lift, push, pull and carry up to 50 lbs.
- In general, the position requires a combination of sedentary work, and/or walking
- May be around moving equipment and machinery.
- May work around chemicals such as alcohol, acids, buffers, and diatomaceous earth that may require respiratory protection.
- May be working in a loud area that requires hearing protection and/or other protective equipment to be worn.
- Must be able to work in controlled or clean room environments requiring special gowning. Would be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these environments.
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required.
- May be required to travel for business reasons, e.g. training and meetings.