The Quality Assurance Control Specialist is a quality focused individual who ensures documentation and record keeping processes conform to cGMP and regulatory requirements as well as Bell Int. Labs procedures and output documents are accurate. The individual will assist in the day to day record management activities within Bell Labs complying with company and regulatory requirements.
Performs QA document control functions, including document login, tracking, processing, review, distribution, release and archiving of documents.
Coordinates the revision, review, and approval and obsoleting of SOPs and other GMP documents. Responsible for ensuring area managers perform annual review of all cGMP documents and SOPs.
Organizes and ensures accurate and reliable filing systems for all paper-based GMP documents.
Maintains in house training programs including training matrix, training files, and annual audit of training files.
Maintain SOP binders.
Maintains change control and deviation processes for SOPs, mater batch records, specifications, test methods, validation protocols/reports, technical protocols, reports, and other GMP documents.
Actively participates in internal audits, customer audits, and other activities as assigned by manager.
Bachelor's degree in scientific discipline preferred
Quality professional with 2-5 years of hands on experience with document management in a regulated industry-pharmaceutical or medical device industry-with direct document control experience.
Must be well-organized and proficient at reviewing and editing documentation.
Can maintain attention to detail while executing multiple tasks.
Must be skilled in the use of MS office applications such as Word, Excel, PowerPoint, and Adobe Acrobat.
Must be self-motivated with ability to handle, organize, and prioritize multiple tasks and able to perform under pressure to meet deadlines.
Ability to effectively build and maintain relationships, communication, and interacting in a matrix environment.
Exhibit a quality mindset and a willingness to develop yourself and others.
Demonstrated knowledge of GMPs, 21 CFR 210 and 211, and other regulatory agency requirements sufficient to apply to quality operations and compliance.
Audit or inspection experience preferred.