Spec 1, Quality Control

TechDigital Group; Cockeysville (MD); On-site; USD 52,000 - 68,000; Full time

Job summary

TechDigital Group in the United States is seeking a Quality Control Associate to perform routine and non-routine testing of raw materials, in-process samples, and finished products according to SOPs and product specs.

You will work within GMP/GDP/GLP frameworks, document results in SAP, and support cross-functional teams to uphold product quality. The role requires strong attention to detail and the ability to thrive in a fast-paced environment.

Qualifications

• Laboratory related certificate from accredited institution.
• Strong understanding of GMP/GDP/GLP regulations and quality management systems.
• Excellent record-keeping and documentation skills.
• Ability to work both independently and in a team.

Responsibilities

• Perform routine and non-routine quality control testing on materials and products per SOPs and specifications.
• Safely handle hazardous materials following safety policies.
• Operate, calibrate, maintain, and troubleshoot lab equipment to ensure accuracy.
• Document test results and activities in records and SAP.
• Support investigations of OOS results and recommend corrective actions.
• Ensure compliance with GMP, GDP, GLP and company policies.
• Collaborate with Quality, Manufacturing and Scientific Operations teams.
• Provide support across multiple QC laboratories as needed.

Skills

GMP/GDP/GLP understanding

Attention to detail

Documentation

Team collaboration

Education

Laboratory related certificate

Tools

SAP

Job description

JOB DESCRIPTION
Job Description / Responsibilities:

• 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.