Location:
Minnetonka, MN (onsite 4 days per week)
Schedule:
Standard Office Hours (Monday - Thursday, 8:00am - 6:30pm)
Duration:
4-Month Contract
The Senior Quality Control Technician is responsible for performing independent reviews of materials and documentation from both internal manufacturing and external suppliers to assess material acceptability. This role also involves supporting Quality Engineers through data gathering, analysis, and quality management system (QMS) maintenance.
Essential Duties and Responsibilities:
- Maintain cleanliness and organization within the laboratory environment and handle materials according to proper procedures.
- Conduct lot release testing, document results on data sheets, and perform basic statistical analysis as needed.
- Perform receiving inspection activities, including verifying specifications, conducting visual examinations, and taking variable measurements. Reject and coordinate returns of unacceptable materials.
- Independently review work performed by fellow Technicians to ensure accuracy and completeness.
- Assemble sample products for testing purposes as needed.
- Record and document inspection results through reports, logs, and database entries.
- Monitor and report observations related to incoming product quality to Quality Engineering or Quality Management.
- Ensure measurement equipment is properly set up and calibrated as required.
- Generate and maintain Non-Conformance Reports (NCRs) and Deviation Reports.
- Participate in Quality System improvements by contributing to the Corrective and Preventive Action (CAPA) process as an owner or contributor.
- Proactively identify opportunities for continuous improvement, propose modifications to procedures, and submit changes for approval.
- Interface with suppliers regarding lot release and related quality concerns.
- Collaborate with engineers to develop and refine lab procedures and methods for product inspection and evaluation.
- Collect and facilitate data for monthly, quarterly, and annual performance metrics.
- Lead training exercises within areas of functional expertise.
- Support internal and external audit activities as assigned.
- Assist internal manufacturing operations as needed.
- Provide leadership and mentorship to QC team members, including onboarding and training new hires.
- Ensure compliance with all applicable company policies and procedures, maintaining current training records.
- Perform other duties as assigned by department management.
Educational Requirements:
- Minimum of a high school diploma.
- Two years of vocational technical training or eight years of relevant experience preferred.
Years of Experience:
- A minimum of eight years in a quality control role, preferably with exposure to ISO and GMP systems and requirements.
Other Skills and Abilities:
- Strong problem-solving skills and the ability to exercise sound judgment in challenging situations.
- Effective communication skills to promote collaboration within and across organizational teams.
- Ability to work effectively with technical services, R&D, manufacturing, and regulatory affairs.
- Proficiency with Microsoft Excel, Minitab, or other data analysis software for compiling and trending data.
- Knowledge of GXP, 21 CFR, ISO, QSR, and other relevant regulations, standards, and guidelines.
- High level of integrity and a strong focus on patient safety and customer satisfaction.
- Technical knowledge in a manufacturing and operations environment.
- Ability to communicate quality assurance/control principles to stakeholders, management, and customers.
- Capability to work with internal teams and third-party partners.
- Ability to handle light mechanical duties and manage multiple tasks with changing priorities.
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