Job Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
Job Description
:
The primary role of Manufacturing Quality function is to design, implement and monitoring quality control programs. Key deliverables include, but not limited to, recommending changes to methods, procedures and standards to improve quality of output based on analysis of data and systems. Ensures products are built correctly to specification, quality standards and appropriate regulatory compliance. Reports defects and tracks until resolution.
Responsibilities:
- The primary objective of QA Engineering (MQ_Quality) specialization within Manufacturing Quality Job Family is to design, implement and maintain quality assurance protocols and methods for processing materials into partially finished or finished products for supply chain.
- Responsible for planning, implementing and managing compliance of in-house and outsourced manufacturing and production processes with internal and external quality and regulatory standards requirements for global distribution.
- Reviewing methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and components, assemblies and/or finished products.
- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
- Assures compliance to in-house and/or external specifications and standards (i.e.
- MP, ISO, MDSAP).
- Leads / facilitates investigations with cross functional team, to resolve and prevent recurrence of product and component issues in the supply chain by identifying appropriate root cause/s and corrective action/s.
- Performs work in a specialized area of expertise that requires knowledge of fundamental themes, principles and concepts. Typically requires a university degree or equivalent work experience.
- Performing routine professional-based activities (early in career).
- Contributing to and managing projects (mid-career).
- Providing advice/direction in primary areas of expertise (specialist and expert).
- Leveraging professional expertise and relationships to contribute to strategy and drive business results (principal)relationships to contribute to strategy and drive business results (principal) .
- Builds productive internal/external working relationships.
- Occasionally leads the work of project teams and might formally train junior staff.
Requirements:
- Bachelor's degree.
- Minimum of 2 years of related experience.
- Developing professional expertise, applying company policies and procedures to resolve a variety of issues.
Interview Process:
- 1st Round: Teams interview with Hiring Manager.
- 2nd Round: In-person interview with Hiring Manager for tour facility and environment.
PMO Notes:
- Must have knowledge of ISO Medical Devices 13485.
- The team is completing an ISO Audit in October and is looking for this skill set.
- The HM is frustrated with resumes that exaggerate or falsify achievements (e.g., claiming to develop a QMS with limited experience).
- HM has found success in candidates who have completed CSUN's master's program in manufacturing with a green belt certificate.
- Currently, the position is on site at Resumed Motor Technologies in Chatsworth (9540 De Soto Ave, Chatsworth, CA 91311). The site is moving to Calabasas (resumed Los Angeles), targeting a September/October move timeline. The candidate should understand the move situation and be okay with the expectation to be fully on site 5 days/week at both locations (Chatsworth to start, Calabasas later in the year).
Must have:
- Bachelor's degree.
- Minimum of 2 years of related experience.
- Must have working knowledge of ISO Medical Devices 13485.
- Experience in developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Additional Information
All your information will be kept confidential according to EEO guidelines.
Job Tags
Contract work, Work experience placement, Immediate start,