Spec 1, Quality Control

Job Description

Job Description

JOB DESCRIPTION

• Perform routine and non-routine quality control testing on raw materials, in-process samples, and finished products in accordance with established Standard Operating Procedures (SOPs) and product specifications.

• Safely handle hazardous materials, including chemicals and infectious agents, while strictly following company safety policies and procedures.

• Operate, calibrate, maintain, and troubleshoot laboratory equipment to ensure accurate testing and reliable performance.

• Accurately document test results, observations, and activities in laboratory records, test sheets, and electronic systems such as SAP.

• Support investigations of out-of-specification (OOS) results by identifying potential root causes and contributing to corrective action recommendations.

• Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Good Laboratory Practices (GLP), and all company policies and procedures.

• Collaborate cross-functionally with Quality, Manufacturing, and Scientific Operations teams to support product quality and operational goals.

• Provide support across multiple Quality Control laboratories as needed, working within various lab functions rather than maintaining a permanent laboratory assignment.

  The associate must be able to sit, walk and stand for extended periods of time and up to 4 continuous hours, lift and carry items weighing up to 25 pounds independently, and keep detailed handwritten records. The associate must be able to use personal protective equipment such as lab coats, respirator masks, gloves, non-permeable full cover shoes and safety glasses for extended periods of time.

Required Qualifications:

• Laboratory related certificate from accredited institution

Preferred Qualifications :

• Bachelor's degree in Biology, Microbiology or other related Life Science preferred.

• 1 year practical experience in Microbiological or medical technology laboratory preferred.

Skills and Knowledge :

• Understanding of GMP/GDP/GLP regulations and quality management systems.

• Strong attention to detail and ability to maintain accurate records.

• Ability to work independently and as part of a team in a fast-paced environment.

• Good problem solving, trouble-shooting skills, and communication skills.