The QA associate will be an integral contributor to the development and application of the quality management system, assist in internal audits, schedule QA related events, assist with regulatory affairs documentation and participate in creation and implementation of control procedures.
Responsibilities:
- Participate in the development of quality management system and document control
- Quality assurance documentation for daily lab and company operations
- Participation in regulatory affairs documentation
- Assist in document writing, review, and formatting
- Documentation management, maintenance, and archiving
- Ensure compliance with documented policies and procedures
- Assist with managing the training program and periodic compliance functions
- Perform and support internal and external audits and regulatory inspections, as required.
- Identify gaps in systems and procedures
- Perform other tasks as assigned
Qualifications:
- Primary skills and knowledge required include, but are not limited to the following:
- 1-3 years in quality assurance in medical devices or bio/pharma
- Experience with regulatory affairs documentation is desirable
- Laboratory experience (preferred)
- Working knowledge of 21 CFR 820 QSR, ISO 13485, ISO 14971, CLIA regulations (preferred)
- Bachelor’s degree or higher
- Self-motivated individual with a desire to expand QMS knowledge.
- History of developing and maintaining controlled procedures.
- Ability to work independently in an extremely fast-paced, dynamic environment
- Must be a team player with good interpersonal skills
- Excellent problem-solving, organization, and communication skills.
- Proficient in Microsoft Office Suite
