Senior Quality Control Technician

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The Quality Control (QC) Technician will play a critical role in planning/coordinating testing and inspection activities related to company products, and recording, analyzing and approving results during product development and manufacturing. The QC Technician is also responsible for environmental monitoring and contamination control activities. The ideal candidate is a highly versatile and meticulously detail-oriented individual with a quality control background and a strong foundation in Microbiology.

This is a full-time, on-site position.

• Technical:
  • Plan, perform and report inspection & routine testing of incoming materials, utilities, products (intermediate and finished), and validation samples.
  • Coordinate, plan, and collect environmental monitoring (EM) samples of production areas and utilities.
  • Release of incoming (raw) materials.
  • Coordinate with external test laboratories and sterilization facility for sample submission, testing, processing, and reporting of results.
  • Implement and maintain QC databases, to ensure that relevant information is up to date and accessible to relevant functions.
  • Initiate and/or review Quality Indicators (Qis), including, but not limited to, deviations and out of specification (OOS) reports related to QC activities.
  • Coordinate, plan and perform equipment calibration and maintenance activities for QC equipment.
  • Participate in product development and risk management activities, as needed.
  • Train existing and new QC personnel, as required.
  • Coordinate and plan Quarterly Dose Audits (QDA).
  • Support test method, process, cleanroom, and equipment validation activities.
  • Inspect product labels.
  • Review and verify batch production records, QC testing data, and logbooks for accuracy, completeness, and compliance with internal procedures prior to product release recommendations.
  • Maintain equipment, production, and other quality records, as needed.
• Quality Management System (QMS):
  • Support development and maintenance of quality control procedures and related documentation, including but not limited to specification documents and testing procedures.
  • Understand relevant quality control requirements.
  • Suggest possible improvements to current testing and identify needs for changes in the Quality Management System.
  • Assist the CAPA Process Owner investigating and resolving non-conformances, ensuring thorough root cause analysis and effective corrective actions.
  • Support internal, supplier, and external regulatory audits (FDA, Notified Bodies), as needed.
• Safety/Organizational/Productivity:
  • Know, understand and adhere to all safety standards, i.e., emergency preparedness, chemical, infectious agents and radioactive hazards.
  • Participate in the introduction and evaluation of new procedures, supplies and equipment to the extent necessary for proper and safe performance of work activities.
  • Ensure proper training of colleagues, as necessary.
  • Use resources (equipment, disposables, time) in a responsible, cost-effective manner.
  • Ensure QC laboratories are clean and organized.

• Education:
  • Bachelor’s degree in microbiology, biology, life science, or a related field.
• Experience:
  • Minimum 3 years of experience in quality control in the medical device industry or contract laboratories.
  • Applicable knowledge of ISO 13485, 21 CFR Part 820, and other applicable medical device regulations.
  • Working knowledge of MRP or MES systems, preferably in Microsoft Dynamics 365.
  • Experience working in laboratory and cleanroom settings.
  • Proficient in using quality management software and tools.
  • Experience with analytical instruments.
• Skills:
  • Strong attention to detail and ability to follow precise work instructions.
  • Adaptability to changes in priorities and exceptional time management to meet deadlines.
  • Work well independently, as well as being able to work cooperatively in a team of professionals with commitment to collaborative problem-solving and the ability to maintain professional working relationships under pressure.
  • Effective communication and presentation.
  • Willingness to mentor other team members and…