CAPA Quality Engineer
Description
Ideal Qualities
- Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
- Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
- Willing to work hands on with multiple clients throughout Southern California
- Ensures activities are efficient, optimized, and client centric.
- Highly motivated and organized, solutions-oriented leader
- Curious and adaptable - has the ability to transform knowledge into actionable activities
- Able to produce results in a fast paced, collaborative environment
Essential Duties and Responsibilities
Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The
level of knowledge expected will be commensurate with the level of incoming experience.
- Oversee and manage CAPA processes from start to finish, serving as a technical investigation leader.
- Guide teams in conducting thorough root cause analyses and developing effective solutions, including devising strategies for monitoring their effectiveness.
- Administer eCAPA software systems like TrackWise and ensure CAPA activities related to investigations and action item implementations are monitored.
- Report on the CAPA program status, including trending metrics for actions and solutions, while ensuring all phases of CAPA activity are documented in compliance with applicable standards and procedural requirements.
- Ensure that CAPA records are always in a state of audit readiness and assess CAPA activities and documentation for compliance with internal policies and regulations.
- Participate in CAPA Board activities, perform CAPA tasks in TrackWise, and provide guidance to CAPA owners on best practices.
- Collaborate with engineering and support functions to maintain quality standards and implement methods for inspecting, testing, and evaluating corrective actions.
- Support all design control activities related to New Product Development and Sustaining Engineering, lead risk management activities, and ensure compliance with regulatory standards.
- Guide cross-functional teams assigned to product CAPAs to ensure that corrective and preventive actions are effective, do not adversely affect the finished product, and meet reliability standards.
- Work with all levels of management to ensure CAPA action plans are supported and that necessary resources are allocated for implementation.
- Provide training, raise awareness, and promote enthusiasm within the business for the CAPA process.
Qualifications
- Experience with leading CAPAs and Deviations (Primary Focus)
- Strong interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast-paced multitasking environment.
- BS in Engineering, Science or equivalent technical degree.
- 5+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent written and verbal communication skills; excellent technical writing skills and writing SOPs.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- Working for multiple clients throughout the region.
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