BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Document Control/Quality Assurance Supervisor to work for a leading San Diego biotechnology company.
Document Control/Quality Assurance Supervisor
Under the direction of the Director of Quality Assurance, oversee all QA and document control
related activities including system administration of the MasterControl document control
software. Position includes configuration, routing and release of documents and mastery of the
training module. Must be detail oriented with better than average communication skills.
Experience with MasterControl or Agile required. Must be well versed in ISO 13485 and cGMP
requirements. Experience in an IVD development and manufacturing environment preferred.
ESSENTIAL FUNCTIONS/MAJOR RESPONSIBILITIES:
System Administration and oversight of the Master Control Software including
responsibility for training as required.
Supports the overall quality management system based on FDA and applicable
Supervises the document control department.
Supports quality improvement programs ensuring compliance with internal procedures.
Writes and revises procedures and related documents as needed.
Provides Metrics for Quality monitoring and management review as required and assists
the QA Director in Management Reviews.
Participate in regulatory inspections and other third party audits as needed.
Participates as a member of the internal audit team.
Assists in compiling regulatory filing documents and maintaining or directing the
maintenance of computerized files to support all documentation requirements.
Reviews or directs the review of all batch records and quality system records.
EDUCATION AND EXPERIENCE:
B.S. degree or equivalent experience with 3+ years of related experience in an in vitro diagnostic field highly desirable. A minimum of 1 year in a decision making role. Demonstrated proficiency with the QSR and ISO 13485 requirements.
The following skills are required:
Implementing and managing electronic document control systems.
MasterControl or Agile system administration.
Improving work flow processes and quality system procedures.
Possess proven interpersonal skills.
Excellent verbal and written communication skills.
Demonstrated computer proficiency with Microsoft Office Software and appropriate
software tools for implementing changes to documentation.
BioPhase Solutions - 5 months ago