Job Description

SUMMARY

The Quality Control Technologist oversees and executes all quality control testing procedures for raw materials, in-process samples, finished goods, and stability samples. This role ensures adherence to regulatory and internal standards, supports product release processes, and contributes to continuous improvement initiatives. The position provides exposure to diverse lab operations and cross-functional collaboration, fostering professional growth in a regulated environment.

RESPONSIBILITIES

• Independently conduct both routine and non-routine testing on various sample types, including raw materials, intermediates, and finished products, following established SOPs.
• Evaluate and interpret analytical data using statistical methods; maintain accurate documentation in line with Good Documentation Practices (GDP).
• Plan and organize quality control testing schedules to meet production and operational deadlines.
• Monitor and manage inventory of laboratory reagents, controls, and materials; inspect and verify incoming items to support continuous testing operations.
• Coordinate equipment calibration schedules and maintain compliance of laboratory instruments with regulatory and operational standards.
• Participate in and support quality investigations related to deviations, non-conformances, and customer concerns in conjunction with QA/RA departments.
• Collaborate with cross-functional teams and contribute to product improvement and development efforts; assist in manufacturing tasks such as capping and stoppering as needed.
• Train and mentor junior quality control staff, ensuring adherence to procedures and quality standards.

QUALIFICATIONS

• Bachelor’s degree in a relevant scientific discipline (Biology, Chemistry, or Medical Laboratory Science) required.
• 1–2 years of relevant laboratory or quality control experience preferred; MLT/MT certification required (MT preferred).
• Experience specific to DSRV quality control practices is advantageous.
• Proficient in Microsoft Office, especially Excel and Word.
• Strong comprehension of SOPs and ability to follow written and verbal instructions.
• Excellent written communication for documentation and correspondence.
• Effective verbal communication skills for cross-department collaboration.
• Solid mathematical foundation, including familiarity with arithmetic operations, fractions, and decimals.
• Ability to calculate control and reagent needs, applying internal rounding protocols.
• Capable of performing statistical calculations such as mean, standard deviation, and coefficient of variation.
• Demonstrated ability to exercise sound judgment in a laboratory setting.

Job Tags

Similar Jobs