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Quality Assurance Specialist
1 month ago
QA Specialist
6 month+ Contract
ON-site - Boston, MA
Truly looking for someone that has 3ish years of experience
- 100% onsite, and looking for a person that finds the different thing everyday nature of their environment as a positive and chance to learn
- Current systems is old school, manual tracking and training implementation
- because of above super proficient in Excel, Word and PDF is a must
- exp. with formatting a submission for drug master file is a major plus
POSITION SUMMARY
My client is seeking a motivated individual to join our biotech company as a Quality Assurance Specialist Contractor to support the development of the novel formulation platform. The individual will join a growing, ultidisciplinary team of scientists/engineers and industry professionals. This Quality Assurance Specialist will report to the Manager of Quality Assurance and will play a key role in supporting the quality management system, including but not limited to the Documentation Management, Training Management and supporting QA activities, as needed. The position is 40 hours a week and fully on-site in our Boston, MA office for a 6-month contract (possibility for extension).
KEY RESPONSIBILITIES
Support the Quality team in the maintenance and development of the Quality Management System GxP
Document Management including:
- Assignment and management of QMS (Quality Management System) document numbers and files.
- Manage the Lifecycle (creation, distribution, revision, retire and obsolete) of GxP documents.
- Maintain and archive electronic signature in compliance with SOP and CFR Part 11 requirements.
- Manage creation and periodic review of QMS SOPs. Draft and revise QA relevant controlled documents. Also, coordinate and assist in the establishment, review and revision of QMS relevant controlled documents by other departments.
GxP Training:
- Develop and maintain GxP training curriculum, training material library. Responsible for archiving and retrieval of completed training records.
- Proficient in Excel and working with spreadsheets to develop training matrices and curriculum
- Delivers training to staff utilizing various media and methodologies as appropriate, including how to use and access documents.
- Format documentation intended for the FDA in support of a Drug Master File (DMF) submission package.
- Perform quality inspections of logbooks that are pending review to ensure compliance and completeness.
- Support the resolution of quality documentation, including deviations, change controls and CAPAs, prioritizing collaboration with interdisciplinary teams to expedite the completion of these records
- Supporting QA in supplier and vendor qualifications, audits.
- Other QA related job duties as assigned by manager
MINIMUM QUALIFICATIONS
- Requires a bachelor’s degree and a minimum of 3+ years of pharmaceutical industry experience with Quality background in a GxP environment.
- Understanding of applicable ICH guidelines and FDA regulations.
- Ability to work both independently with direction and within functional teams, communicate effectively in a cross-functional team environment and demonstrate relationship building skills to attain group goals.
- Advanced knowledge of Microsoft office suite of applications (Work, Excel, SharePoint, etc.)
- Prior experience with Drug Master File documentation formatting a plus.
