Advantage Resourcing is seeking a talented and passionate Scientist II for our client in West Hills, CA.
The Technical Operations team is responsible for equipment validations, process validations, technical transfer and technical support for RUO and IVD TDX HLA Typing kits and reagents. The Scientist II position requires the ability to write protocols, execute studies, and write reports for medium complexity equipment and processes. In addition, the Scientist II may investigate, drive to root cause, and propose solutions for manufacturing challenges of moderate complexity. This position is constantly cross functional in nature and requires independent thought and schedule adherence, under moderate levels of guidance from the Technical Operations team.
Key Responsibilities:
- Write, execute and review equipment validation protocols and reports.
- Coordinate validation activities in support of assigned validation projects working closely with Quality Systems and Subject Matter Experts.
- Complete material assessments
- Write and revise documentation to support operations
- Maintain knowledge and comprehensive understanding of relevant Medical Device regulations and current interpretations affecting equipment, product and process validation.
- Performs root cause analysis and suggest workarounds and/or solutions for recurring issues of moderate complexity.
- Adopts process improvement as a culture and as way of life, and works with Operations & Quality to drive efficiency and implement future state processes.
- Able to work independently, with guidance from Technical Operations team.
- Strong Excel skills required.
- Ability to learn new products and technology at a moderate speed.
- Hands on knowledge of basic microbiological lab skills and techniques required.
- Exhibits a high level of quality (right the first time), integrity (do what you say you are going to do), and cross functional behavior (always stay above the line).
Minimum Requirements:
- Bachelor’s degree in Biology, Chemistry, or other similar Life Science field.
- 3-5 years relevant experience in medical device or pharmaceutical arena.
- Consistently demonstrated validation proficiency, with knowledge of equipment qualification (IQ/OQ/PQ), process validation, and computer/automation systems.
- Good analytical skills, with an ability to use scientific knowledge and statistical methods to identify root causes of process and product failures.
- Strong project management and organizational skills.
- Demonstrated technical skills in process validation & concepts with an emphasis on implementation.
- Excellent verbal and written communication skills.
- Previous experience in problem solving methodology.
- Possess a continuous process improvement mindset
- Proficient in use of Microsoft Office Suite.
- Must be able to travel as needed.
- Performs all job duties in a safe manner
- Performs other duties as assigned.
About Advantage Resourcing
Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.