BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. QA Specialist to work for a leading San Diego biotechnology company.
Sr. QA Specialist
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Maintains contemporaneous electronic and hard copy records and tracking systems for employee training in the documents within the SOP system (e.g. employee individual syllabus, master training logs, master training syllabus). Provide periodic updates of the status of employee training to required documentation. Update the controlled documents system as required. Process new, revised and obsolete controlled documents.
Perform Quality Assurance document audits on research reports to include but not be limited to: Pre-clinical, analytical, formulation, product development, manufacturing/comparability, stability and clinical research reports, Submissions to regulatory agencies, Technical transfer, process validation, and other contract organizationsâ€™ reports, Certificates of analysis, Certificates of compliance, Certificates of testing, Certificates of release. Perform these audit functions by the creation of audit plans, conduct audit of documentation to confirm data/content integrity, report deficiencies as determined by audit, and confirm corrections are carried out. Follow relevant SOPs and instructional documentation, and apply regulatory/compliance guidelines when performing documentation audits. Adhere to project timeliness.
Performs Quality Assurance Internal Quality System Audits in support of the Quality System. Develop annual audit schedules. Develop prospective audit plans, perform audit and provide audit results to the parties responsible for the functions. Report to management monthly on the status of findings and corrective actions. Prepare and report on the comprehensive status of the Quality System in the annual Quality Management Report. Assist with the Annual Product Report to management as required.
External Audits. Performs external supplier and vendor audits as required. Writes audit reports, and follows up on observation close-outs. Assist QA representative at CMO for partner audits as required.
Performs the following support functions as required: Master Batch Record Reviews and Executed Batch Record Reviews and Approvals, Clinical Master Batch Record and Executed Batch Record Reviews and Approvals, Cell Bank Master Batch Record Reviews and Executed Batch Record Reviews and Approvals.
Change Control Function. This position will support the organization with document control including change control to the quality agreement requirements. This position will support the organization with assessments of raw material changes, process changes, and manufacturing support utility changes in relevance to regulatory filings and quality agreements. This position will assist with notifications of change control to partners where required.
This position will play a supportive role in the investigation and trending of product complaints and summarizing product complaints in periodic reporting
This position will provide assistance to bring out of specification results and deviations to closure and the timely implementation of corrective actions.
This position will play a key role in the logistical administration of clinical and commercial product stability studies. Create stability protocols. File, track, and trend stability data. Write or assist with the writing of stability final reports. Author expiration dating documentation for clinical drug product/substance and distribute accordingly to clinical sites, partners, supply and clinical operations personnel, etc.
Performs audits of electronic submissions in draft and final form for content and electronics and formats as needed.
Provides a supportive role with the preparation and revision of chemistry, manufacturing and controls sections and summary sections of IMPD/IND/NDA, annual reports and other submissions as needed.
Performs Quality Assurance activities associated with maintaining other internal Quality Systems such as: CAPA System (issuing, tracking, filing, periodic updates, input into the management report), Training System (new employee training syllabus, new employee training, annual GMP training, etc), Material Review Board System - Responsible for preparing supporting documentation for Material Review Board presentations and meetings.
Provides a supportive role as necessary as a QA representative in regulatory agency audits.
As necessary, this position will assist in drafting Quality Agreements
This position will be responsible for ensuring adherence to quality agreement requirements: Analytical Support, Responsible for providing QA support for specification development, May provide QA oversight for the QC lab GMP activities, May review and approve QC lab test results for QA.
Contract Manufacturing Organization QA Liaison
Perform functions as QA representative on project team
Clinical Operations Support
Provide input into clinical labeling content based upon the regulations governing region of distribution. Approve labels as required.
ADDITIONAL FUNCTIONS AND RESPONSIBILITIES:
Assist with the development, revision, and implement of departmental policies and procedures affecting Quality Assurance.
This position is responsible for adhering to departmental policies and procedures affecting Quality Assurance.
Assist with maintaining file organization within the RA/QA Dept.
Perform other duties as defined.
EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
A Bachelorâ€™s degree in a scientific field is highly preferred; advanced degrees can reduce experience requirements for advance levels.
Minimum of 8 years' experience in the pharmaceutical, device, diagnostic or medical field and appropriate education.
Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
Thorough understanding of GMPs and familiarity of GLPs and GCPs is essential.
Good writing and verbal communication skills.
Ability to work independently.
Good problem solving skills.
Ability to multitask and work within a fast-paced dynamic team environment.