JOB DESCRIPTION
The QA Manager, is a full time position to provide oversight of QA/QC functions. The QA manager will work onsite at our lab located in Novato, CA. The ideal candidate is an exceptionally organized, methodical professional who has the experience necessary to support GxP testing and documentation to meet the requirements of FDA’s 21 CFR Part 210, 211 and 600 regulations. The manager will develop and maintain the Quality Management System and foster a culture in which all employees are actively engaged in quality by design processes.
Marin Biologic Laboratories, (Marin Bio) is a contract research organization working with the pharmaceutical and biotechnology industries. Our scientists develop and validate drug release assays, perform drug stability studies and research surrounding this effort. The scientific areas include molecular and cellular biology, immunology and biochemistry. Marin Bio is a small company that strives for the best quality in our work and communications with our clients, as well as a balanced life for our staff.
RESPONSIBILTIES
- Assist in the development and maintenance of our Quality Management System by writing, reviewing and updating Quality Documents
- Administer the Document Control system including documentation and tracking of requests, approvals and implementation
- Maintain master documents and records, training records, audit files and raw data
- Ensure data integrity compliance, specifically with 21 CFR Part 11 and ALCOA+
- Execute QA and QC operations required to assess, evaluate, and review operations on the research floor and observe real-time observation of activities. Also, identify and resolve issues including proper and timely documentation
- Supports customer audits and regulatory inspections•
- Manage the QMS (Change Control, CAPA, Deviations, Lab Investigations, Complaints, Internal Audits, Training, and Vendor Management). Including review and approval of applicable documentation.
- Ensure compliance of validation and calibration programs.
- Utilize quality tools and techniques to perform and document root cause analysis investigations, evaluate and resolve quality issues, and support continuous improvement
- Perform training and support that covers policies, procedures and core processes
EDUCATION
- Bachelors degree in Chemistry, Biochemistry, Molecular or Cell Biology preferred or equivalent work
- GMP/GDP training and experience
EXPERIENCE
- Minimum 3+ years in Quality Assurance
- Experience managing Deviation, CAPA, Change Control, Audit, Scientific Review, and Quality Control documents
- Knowledge of IQ/OQ/PQ protocols, equipment validation and Continuous Improvement techniques
- Familiarity with basic analytical data analysis and QA/ QC tools and methods
SKILLS REQUIRED
- Knowledge of GMP, GLP and FDA standards
- Good Documentation Practices (GDP) and reporting skills
- Excellent written and verbal communication skills
- Ability to work independently
- Strong Organizational skills
- Excellent problem-solving, analytical and decision-making skills
- Strong attention to detail and timelines
- Deep knowledge of quality assurance terminology, methods and tools
- Microsoft Office skills
- Ability to prioritize and manage several projects and activities simultaneously
- Teamwork and collaboration with MBL staff
- Authorized to work in the U.S.
SKILLS DESIRED
- Strong technical writing/editing skills
- Proficiency in database management
- Experience with Regulatory Inspections with the ability to act as a Subject Matter Expert
- Demonstrates positive attitude, strong work ethic, and self-motivation
- Fast learner, able to react quickly in a fast-paced environment
- Customer Service / Quality Driven
TO APPLY
- Please send resume to accounting@marinbio.com
- A cover letter
- Include 3 references (email, address and phone number, as well as your relationship to each reference)
