Senior QA Validation Engineer Singulex
The ideal candidate for this position at Singulex would have direct experience in managing an in vitro diagnostic or medical device validation program (internally and using Contract Manufacturing Organizations) to ensure validation activities are in compliance with the company?s Quality System and all applicable regulations and standards. Preferably, the candidate would have validation experience with reagent, instrumentation & software products. The candidate in this role would be responsible for designing and implementing validation master plans, writing validation SOPs, managing the Singulex change control process, and would be directly involved in new product scale-up, process optimization, technology transfer and process evaluation activities to current standards.
Develops and manages Singulex?s internal and external (CMO) validation program, coordinates the completion of planned validation activities, and ensures the program is in compliance with the Singulex Quality System and all applicable quality regulations and standards (e.g., QSR, ISO 13485, etc.)
Designs and implements validation master plans for Singulex Diagnostic products incorporating process validations and associated facilities, equipment, computer system, and method qualifications.
Responsible for the Singulex Change Control process for regulated products, including equipment, facilities, processes and computer systems, and assesses potential impact to validation.
Serves as a Singulex reviewer/approver for validation plans, protocols and reports.
Writes necessary Singulex validation procedures.
Provides insight and guidance regarding validation requirements and issues to product development teams and provides validation expertise during the development of production procedures and product specifications.
Supports validation needs in the Singulex Life Sciences and Clinical Lab business areas.
Involved in new product scale-up, process optimization, technology transfer, and process evaluation activities. Brings company and industry knowledge as well as creative technical/scientific skills to manufacturing process development.
Supports on-site audits by our customers and regulatory agencies
Maintains substantial knowledge of state-of-the-art validation principles and theories
Provides value added recommendations for financial performance improvements
Performs other duties as assigned.
Some travel required.
BS/BA degree in Science or related field
3+ years experience in Quality Assurance
5+ years experience with process and equipment validation
Experience with computer system validation is preferred
Direct experience with managing validation activities performed by Contract Manufacturing Organizations is required
Direct experience with validation activities to support manufacture of product in an FDA-regulated industry is required
Validation experience with in vitro diagnostic products (reagent, instrumentation and software) is preferred
Strong understanding of and experience with QSR and ISO 13485 regulatory requirements is required
Strong understanding and experience with Design Control and Change Control is required
Experience with Risk Management preferred
Able to work independently, without instruction
Demonstrated leadership skills and ability to work well with project teams and outside partners
Must have excellent written and verbal communication skills and the ability to understand, prepare, and communicate technical information to a wide range of audiences.
Excellent cross-functional team participation skills.
Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike.
Highly organized and detail-oriented.
Results and goals oriented.
Excellent written and oral communications.
Ability to work in a fast-paced and changing environment; flexible and quickly adaptable to changing priorities.
Ability to inculcate the Singulex ?Top-5? core values and serve as positive example to team members and others within the organization.
Effective personal communication skills, shares knowledge with excellent training skills.
Having integrity and a strong work ethic.
Passionate for both personal and corporate success.
Ability to work independently with minimal supervision and as a member of a team.
Commitment to quality. Enthusiasm, attention to detail, the ability to meet aggressive deadlines, and ability to work effectively with others in a fast paced, highly-productive environment.
||Alameda, CA |