Senior Technician 1, Quality Control

Antares Pharma • Hopkins, MN

122d • $48,000 - $80,000

About The Position

The Senior Technician 1, Quality Control will provide an independent review of materials and documentation, supplied by both internal manufacturing and external suppliers, to determine material acceptability. This position will also assist Quality Engineers with data gathering/analysis and QMS maintenance. In this role, you'll have the opportunity to perform lot release testing, record data on data sheets and summarize, analyze, and perform basic statistical analysis on results when required. Perform receiving inspection activities on incoming materials which can include confirming specifications, performing visual examination and taking variable measurements, and rejecting and returning unacceptable materials. Provide independent, secondary peer review of fellow Technician's work. Assemble sample product as needed for testing purposes. Document inspection results by completing reports, logs, and inputting data into databases. Monitor incoming product quality and report observations upward to Quality Engineering and/or Quality Management. Maintain measurement equipment in an operable state by following setup procedure and monitoring calibration status. Ability to identify when NCRs/Deviations have occurred and report upward. Participate in Quality System Improvements through the CAPA process as a CAPA contributor. Think critically and proactively suggest activities for continuous improvement as opportunities arise during the course of daily work. Propose procedures modifications as appropriate. Collaborate with engineers regarding lot release and related issues. Collaborate with engineers on developing new and modifying existing lab procedures/methods for inspecting and evaluating product. Facilitate data and information collection for use in monthly/quarterly/annual performance metrics. Develop and lead training exercises commensurate with area(s) of functional expertise. Support internal and external audit activities as assigned by manager. Support Internal Manufacturing activities. Provide leadership/mentorship to other members of the QC team, including training of new team members during onboarding. Comply with all applicable company policies and procedures and maintain current training on these records. Work inside a laboratory environment. Ensure cleanliness of QC areas and properly handle materials. Other activities as assigned by departmental management.

Requirements

• 2-4 years of experience working in a quality control role with ISO and GMP systems requirements.
• High school education (an equivalent combination of experience and education may be considered).
• Problem-solver with the ability to exercise sound judgment under challenging circumstances.
• Excellent communication skills with the ability to effectively promote intra-and inter-organizational cooperation.
• Ability to interface with technical services, R&D, manufacturing, and regulatory affairs.
• Familiarity with Microsoft Excel and/or other spreadsheet/database software.
• Familiarity with Minitab preferred.
• Knowledge of GxP, 21CFR, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance.
• Strong character with self-confidence and integrity.
• Strong background in a manufacturing and operations environment.
• Sound technical background and the ability to educate stakeholders, management and customers.

Nice To Haves

• Familiarity with Minitab preferred.

Responsibilities

• Perform lot release testing and record data on data sheets.
• Summarize, analyze, and perform basic statistical analysis on results when required.
• Perform receiving inspection activities on incoming materials.
• Confirm specifications, perform visual examination, and take variable measurements.
• Reject and return unacceptable materials.
• Provide independent, secondary peer review of fellow Technician's work.
• Assemble sample product as needed for testing purposes.
• Document inspection results by completing reports, logs, and inputting data into databases.
• Monitor incoming product quality and report observations to Quality Engineering and/or Quality Management.
• Maintain measurement equipment in an operable state.
• Identify when NCRs/Deviations have occurred and report upward.
• Participate in Quality System Improvements through the CAPA process.
• Propose procedure modifications as appropriate.
• Collaborate with engineers regarding lot release and related issues.
• Facilitate data and information collection for performance metrics.
• Develop and lead training exercises.
• Support internal and external audit activities.
• Provide leadership/mentorship to other members of the QC team.
• Ensure cleanliness of QC areas and properly handle materials.

Benefits

• Full and comprehensive benefit program, including an Employee Stock Purchase Program and 401(k) matching.
• Opportunities to grow in a culture that prioritizes learning, development and progression through in-house programs and tuition reimbursement.
• A collaborative, innovative team that works as one to amplify your impact.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED