Quality Assurance Officers

Work Schedule Standard (Mon-Fri) Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
This is a fully onsite position based at our Cranbury, NJ site. Unfortunately, relocation assistance is NOT provided. Priority will be given to LOCAL candidates currently residing in Cranbury area.
Our Recombinant Proteins (REP) Business Unit in Cranbury, NJ is part of our Biosciences Division. REP unites deep scientific expertise with a collaborative culture to build a product portfolio that includes cytokines, growth factors, antibodies and ELISA kits used to support the research of our academic, government, biotech, and pharmaceutical customers.
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.
Conduct and assist with internal and external audits, including Quality Management System audits
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)
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
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
Bachelor's degree with 3 years of experience, OR
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)
Proficiency in Microsoft Office, Excel, PowerBI
Technical writing and documentation skills
Ability to work independently and without direct supervision
Ability to create, revise and interpret complex technical documents
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
Experience conducting internal audits and supporting external regulatory inspections
Project management and organizational skills
Up to 10% travel may be required
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount