Job purpose

This position is a senior quality control position. The position performs routine and non-routine analytical testing and performs regular data entry and analysis for lot release of in vitro diagnostic products, assays and reagents. Responsible for in line production quality assurance inspections, batch record (device history record) reviews, and product release.

Roles and Responsibilities

Utilize basic scientific principles, practices and existing technologies.

Quality Control Testing

- Perform laboratory lot release testing and other analytical testing using laboratory equipment such as pipettes, centrifuges, plate shakers, plate readers and specialized test instruments.

- Collect and enter data on batch records and into controlled spreadsheets.

- Perform troubleshooting to investigate discrepancies and solve problems.

Quality Assurance Reviews

- Perform QA review of products. Monitor and inspect products to ensure that quality and package/label integrity are within specifications.

- Verify that product codes, labels, cases, cartons are correct.

- Ability to construct, interpret and apply written deviations to the product and production/test process as applicable.

- Ability to construct, disposition, and verify implementation of written non-conforming material reports as applicable to the product.

- Perform DHR (device history record) review and lot release. Ensure batch records meet content and compliance requirements. Ensure lot acceptance testing data and summaries are clear and complete. Complete product lot dispositions.

General Lab Maintenance

- Maintain laboratory materials stock.

- Maintain laboratory cleanliness and maintenance activities.

- Utilizing and filing internal forms to document activities.

Prepare and maintain production retain samples.

Complete and maintain documentation associated with quality checks.

Effectively communicate technical and analytical data using reports, charts, graphs, etc.

May work without the supervision of a management level team member.

Helps to train new team members and remains available to them as an SME on lab testing and processes.

Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, and processes.

Carry out special projects like investigation testing, validation activities, and stability monitoring.

Participate in quality improvement initiatives and activities such as internal auditing, equipment management, and procedure creation/revision.

Other duties as required.

Qualifications and Requirements

Must have the ability to work a Monday-Friday, 8am - 5pm daily work schedule. Occasional weekend work may be required.

Ability to carry out assigned tasks in a timely manner.

Good time management skills, ability to coordinate and execute multiple tests simultaneously.

Flexibility to handle changing priorities and deadlines while maintaining a high quality of work.

Good verbal and written communications skills.

Ability to perform complex laboratory skills in a safe manner.

Ability to record, understand, interpret, and effectively communicate technical data.

Strong problem-solving skills with the ability to analyze and effectively solve problems.

Ability to work independently. Motivated self starter.

Ability to effectively communicate with interdisciplinary team of biochemists, scientists and engineers.

Willingness to work in a laboratory environment. Willingness to work with blood samples that have been screened according to regulatory requirements.

Proficient computer skills with the knowledge and ability to collect, document, and interpret analytical data.

Maintain detailed and comprehensive laboratory books when necessary.

Exceptionally competent in lab environment: testing, troubleshooting, documentation, set-up, training, problem solving.

Experience in wet chemistry techniques especially micropipetting, extractions, titrations.

Experience with Microsoft Word and Excel.

Experience working in an FDA regulated in vitro diagnostic facility using state-of-the-art and advanced techniques and procedures desired. GMP (Good Manufacturing Practices) experience desired.

Familiarity with CLSI guidelines preferred.

Education and Experience

BS degree with 4+ years of experience or NC BTEC (Biomanufacturing Training and Education Center) relevant certification(s) with at least 3 years experience.

4+ years of industry experience in an FDA regulated analytical test laboratory environment preferred.

Additional

The role is based in a lab and will spend considerable time on the production floor with considerable time spent standing. Required personal protective equipment (PPE) will be provided.

This position is very active and requires regular standing, walking, twisting, grasping, reaching, bending, kneeling, sitting, stooping. Manual finger, hand, and arm dexterity, and ability to work around cramped and tight spaces will be needed. Specific vision abilities required by this job include close vision, distance vision, color vision to detect color-changes in testing and labeling, peripheral vision, depth perception, and ability to adjust focus.

Compensation & Benefits

Baebies offers a dynamic and welcoming work environment surrounded by intelligent, driven, and creative people. Guided by the vision that everyone deserves a healthy start, our team is devoted to our customers and to advancing technology in early disease detection and comprehensive diagnosis. At Baebies, we look for people who are innovative, dedicated to our mission, and constantly striving to improve the status quo.

In addition to competitive, market-driven compensation, Baebies provides a comprehensive employee benefits package including:

100% employee premiums for Medical & Vision coverage

100% employee and family premiums for Dental coverage

401K available

Stock Options

4 Weeks PTO

14 Paid Holidays per year

Paid Employee Life Insurance

Onsite free gym membership & classes

Discount Pet & Legal Insurance

Fertility & Family Support

Much more!

Pay: $45,000-68,000 annually

Baebies, Inc. is an equal opportunity employer. NO RECRUITERS OR AGENCIES, PLEASE.

Compensation details: 0 Yearly Salary

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BAEBIES INC jobs

Senior Quality Control Technician