The Sr. Quality Specialist works closely with members of the project team to ensure that product development is conducted in compliance with internal and external design control processes. The incumbent provides quality assurance input during the development process. The Sr. Quality Specialist exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
The Sr. Quality Specialist plays a key role in controlling product from receipt or manufacture through final disposition, supporting complaint investigations, reviewing/approving deviations, reviewing/approving validations, and participating on the Material Review Board (MRB) as required. Reviews and approves change control activities as they relate to Manufacturing Operations. Provides input to procedural changes, technical reports and validations as appropriate. Oversee the metrology program. Responsible for assuring compliance to in-house specifications and cGMP, ISO and other standards as applicable.
The Sr. Quality Specialist must have a solid background in cGMP compliance in support of medical device and/or pharmaceutical manufacturing operations. A working knowledge of cGMP, QSRs, ISO standards, and other applicable regulations is required. The position also requires the ability to: audit procedures, data, and processes, effectively interact with all levels of personnel, multi-task and prioritize activities, and in general have the ability to be flexible.
May serve on cross functional teams to investigate problems and address issues.
Proficient in MS computer applications: Outlook, Word, Excel, others as required.
MAIN TASKS (PRIMARY RESPONSIBILITES) OF THE POSITION:
- Maintenance of the Design History and Risk Management Files for multiple development projects.
- Oversee that documents filed in the Design History and Risk Management Files, are compliant with FDA regulations and ISO standard on design control (21CFR820.30 and ISO 13485:2003) and Risk Management (ISO 14971:2007).
- Provides Quality Assurance input during product development including, but not limited to, establishment of product specifications, definition of DHF document architecture and application of statistical methods.
- Auditing, Change Control, Deviations, CAPAs, SCARS, Complaints, and Validation Review.
- Other duties as may be assigned.
- None - this is an individual contributor position, but may be called upon to coordinate team activities with other multi-disciplinary team members.