Reagent QC Associate

at  BioGx Inc

Pay Range: $42,000-$44,000
BioGX is a global molecular diagnostics company focused on the health and safety of communities all over the world. We design, develop and manufacture products and devices for Clinical, Water Quality, Food Safety and Pharma Quality. We are headquartered in Birmingham, AL.
The Reagent QC Associate I is responsible for general laboratory duties focused on Quality Control of standards, controls and panels for commercially available nucleic acid tests and other advanced reagents. The Reagent QC Associate I will work under the direction of the Quality Control Supervisor and is expected to follow standard operating procedures and quality systems documentation.

Essential Duties and Responsibilities (other duties may be assigned):

• Coordinates and executes reagent manufacturing Quality Control procedures
• Compiles and submits manufacturing QC data and batch records for QA review and approval
• Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
• Assists in inventory management and ordering materials
• Assists in the development of reagent manufacturing QC processes and documentation
• Assists in maintaining production and laboratory equipment
• Assists in the development of physical quality specifications and tests
• Assists in testing raw materials for reliability and stability
• Assist in transferring processes from development to manufacturing
• May assist in process scale-up to transition from pilot lots to full production-scale manufacturing
• Complies with ISO 13485 and cGMP standards.
• Supports continuous quality improvement

Supervisory Responsibilities: N/A

Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Proven ability to deliver productivity to plan
• Must have excellent communication skills (listening, written, verbal, presentation)
• Strong technical skills, including a working understanding of molecular biology and biochemistry
• Demonstrated analytical, troubleshooting, and problem-solving skills
• Proven math skills
• Experience with Microsoft Word and Excel
• Demonstrated attention to detail
• Strong written and verbal communication skills
• Proven ability to meet deadlines and work under aggressive timelines
• Demonstrated ability to work effectively in a team environment
• Accurate and precise manual pipetting and measuring techniques
• Experience working with automated dispensing equipment is preferred, but not required

Education and Experience: B.S./M.S. in molecular biology or related field with at least 2 years of hands-on experience in reagents manufacturing

Essential Duties and Responsibilities (other duties may be assigned):

• Coordinates and executes reagent manufacturing Quality Control procedures
• Compiles and submits manufacturing QC data and batch records for QA review and approval
• Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
• Assists in inventory management and ordering materials
• Assists in the development of reagent manufacturing QC processes and documentation
• Assists in maintaining production and laboratory equipment
• Assists in the development of physical quality specifications and tests
• Assists in testing raw materials for reliability and stability
• Assist in transferring processes from development to manufacturing
• May assist in process scale-up to transition from pilot lots to full production-scale manufacturing
• Complies with ISO 13485 and cGMP standards.
• Supports continuous quality improvemen

Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Proven ability to deliver productivity to plan
• Must have excellent communication skills (listening, written, verbal, presentation)
• Strong technical skills, including a working understanding of molecular biology and biochemistry
• Demonstrated analytical, troubleshooting, and problem-solving skills
• Proven math skills
• Experience with Microsoft Word and Excel
• Demonstrated attention to detail
• Strong written and verbal communication skills
• Proven ability to meet deadlines and work under aggressive timelines
• Demonstrated ability to work effectively in a team environment
• Accurate and precise manual pipetting and measuring techniques
• Experience working with automated dispensing equipment is preferred, but not require