DESCRIPTION
We are seeking a highly motivated and meticulous Quality Systems Specialist to join our team. The Quality Systems Specialist will play a meaningful role in the implementation, maintenance and improvement of the company's quality assurance program, the Quality Management System (QMS) and ensuring that other departments operate in accordance with the highest quality standards and adhere to all applicable requirements. This position functions under the supervision of the Quality Manager.
What will you do:
- Maintain the company's QMS based on ISO 9001:2015 standard
- Conduct and assist with internal and external audits, including Quality Management System audits
- Facilitate the identification, investigation and effective closure of deviations, non-conformances, corrective and preventive actions (CAPAs), etc.
- Lead and manage root-cause investigations and facilitate problem-solving initiatives to implement effective corrective actions and drive process performance improvement (GMP OOSs, NCRs, DRs, CAPAs, and Change Controls)
- Coordinate in-house and external QC testing activities including sample submissions, results analysis, and reporting for WIP and finished goods. Tests include Biological Assays, HPLC, SDS-PAGE gels, Endotoxin, ELISA, Protein Concentration by UV Spectroscopy, Mass Spectrometry, Western Blot, Mycoplasma, Sterility, and Residual E.coli DNA testing
- Manage GMP finished product lot release and material disposition (Quarantine, Hold, Release, Rework, Scrap)
- Coordinate and implement GMP media fill challenges
- Review quality-related documentation such as manufacturing batch records, worksheets, and training forms for legibility, accuracy and completeness
- Ensure the accuracy, accessibility and version control of key company documents, including SOPs, work instructions, test methods and checklists
- Perform daily tasks critical to seamless operation, including material and product quarantine and release, batch record and label issuance
- Manage product complaints and investigations, and authorize replacements, credits and refunds stemming from technical investigations
- Analyze quality data such as environmental monitoring and complaints to identify quality issues and recommend corrective and preventive actions for continuous improvement
- Establish and manage systems for collection and analysis of statistical data, monitor and predict trends that may affect product quality
- Oversee site cleanroom integrity, contamination control, and state of control
- Complete and review quality questionnaires and desk audits
- Manage customer CDAs/NDAs
- Support maintenance of the Supplier Management Program
- Generate and disseminate change notifications, customer notifications, and product documentation (Certificates of Analysis, Certificates of Origin, Safety Data Sheets, customer letters)
- Manage equipment maintenance programs with Facilities and maintain Quality Assurance-owned equipment
- Monitor and report on site quality metrics
- Collaborate with other departments to develop and maintain a robust QMS
- Follow all ISO 9001 and GMP guidelines
- Demonstrate and drive the Thermo Fisher values – Integrity, Intensity, Involvement, and Innovation (The Four I's)
REQUIREMENTS
Education:
- Advanced degree with at least 1 year of experience, OR
- Bachelor's degree with 3 years of experience, OR
- Technical education equivalent to a 4-year college degree with 3 years of experience may be considered
Experience:
- Prior experience working in a controlled GMP environment is ideal
- Good understanding of ISO 9001 standard preferable
Knowledge, Skills and Abilities:
- Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
- Strong knowledge of cGMP regulations, QMS, ISO standards (9001/13485), and international regulatory requirements
- Experience with quality management systems and documentation (TrackWise, OCPLM, Master Control, or equivalent)
- Experience in
- Proficiency in Microsoft Office, Excel, PowerBI
- Technical writing and documentation skills
- Analytical and problem-solving abilities
- Strong communication skills (written and verbal)
- Ability to work independently and without direct supervision
- Ability to work collaboratively in cross-functional teams
- Ability to create, revise and interpret complex technical documents
- Consistently exhibits a high level of attention to detail
- Strong organizational skills, including the ability to handle multiple projects, prioritize and thrive in a fast-paced environment
- Ability to define problems, collect data, investigate, and solve problems efficiently
- Proven track record of conducting presentations and trainings
- Experience conducting internal audits and supporting external regulatory inspections
- Project management and organizational skills
- Ability to work in cleanroom environments and follow gowning procedures where required
- Up to 10% travel may be required
- Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs
