Job Details
Job Description
Sentinel is a single-use assembly fabricator and process components distributor servicing the
Biotech, Pharmaceutical, and Cell & Gene research and manufacturing industries. Our facility
consists of an ISO 7 Cleanroom as well as warehouse and office space to support our operations.
Additionally we are in the process of obtaining ISO 9001:2015 certification. Due to recent growth we
are looking for a Quality Assurance Lead to focus on maintaining, improving, and expanding our
quality systems.
Principal Responsibilities and Essential Duties:
Manage all facets of the Quality Management System, ensuring its effectiveness and
alignment with organizational goals.
Secure and/or uphold ISO 9001:2015 compliance and certification standing.
Spearhead improvement initiatives, driving updates to Quality systems and procedures,
designing and drafting new systems and procedures as necessary
Conduct thorough investigations, root cause analyses, and effectiveness reviews with
respect to CAPAs.
Execute or oversee the execution of existing Quality systems and procedures, ensuring
adherence to established standards.
Foster a culture of Quality awareness and facilitate comprehensive Quality training across all
levels of the organization.
Identify and document change controls, ensuring timely customer notification when
required.
Successfully host external audits (customer, certification body, etc.) maintaining Sentinel's
approved status.
Strategize, plan, and perform internal audits at regular intervals to uphold Quality standards.
Address supplier quality issues, aiming to enhance supplier rating scores.
Coordinate the compilation of data for Quality management review meetings, prepare
reports, and lead these sessions.
Develop and supervise the implementation of equipment qualifications and process
validations. Ensure the accuracy and currency of verification, calibration, and maintenance
activities.
Take appropriate actions in response to nonconformances and customer complaints.
Apply a risk-based approach, documenting risk analyses when applicable, and
communicating critical risks to senior leadership.
Leverage data, metrics, and trend analysis to monitor and evaluate the performance of
Sentinel's Quality initiatives and guide improvement efforts.
Pursue additional quality-related certifications and capabilities as directed by senior
leadership (ex: validated sterility, leak testing, particulate testing, etc.)
Maintain compliance to customer Quality agreements, and complete customer supplier
surveys when required.
Requirements
Education and Experience Qualifications:
Bachelor's degree in a relevant field such as Quality Management or science-based
discipline (ex: Biology, Chemistry, Engineering, etc.) preferred
Minimum of 3-5 years of experience in Quality Assurance, preferably in the
biopharmaceutical, medical device, or other regulated manufacturing industry
Proven track record of implementing and managing Quality Management Systems, in part or
entirety, under ISO 9001 or equivalent industry standard strongly desired
Experience with quality control methodologies, statistical analysis, root cause analysis,
corrective action effectiveness review, risk management, and quality improvement initiatives
Demonstrated leadership skills with the ability to mentor and promote quality principles and
techniques throughout the organization
Benefits
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance