QC Analyst 2

bioMérieux•Durham, NC

11d•$24 - $36

About The Position

The QC Biochemistry Analyst 2 role is responsible for routine Biochemistry testing. The responsibilities of this position include: • Testing of raw materials, intermediates, special test requests, and finished product samples per standard operating procedures.• Investigational writing of INVALID reports. • Provide input and support for Out of Specification reports. • Serve as a certified trainer for laboratory testing as applicable.

Requirements

High School Diploma, GED or equivalent
4+ years of experience working in a regulated Biochemistry or Chemistry laboratory (FDA, ISO, USDA, etc.) with GxP testing
Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
Excellent and effective verbal and written communication skills.
Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.

Nice To Haves

Bachelors degree highly preferred in Chemistry, Biochemistry, or Biomedical
Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).
Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)
Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.

Responsibilities

Participates as a trainer for Quality Control testing and instrument maintenance.
Troubleshoots simple to moderate Biochemistry laboratory equipment related issues.
Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.
Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.
Executes laboratory investigations as assigned by management in compliance with procedures.
Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.
Assists with revisions to QC department standard operating procedures (SOPs) as directed by management.
Ensures personal training is maintained to current department processes and procedures.
Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
Participate in improvement initiatives as directed by management.
Work with other departments and assist with executing validation protocols associated with Biochemistry laboratory equipment, associated software, and procedures including revalidation as scheduled or required to maintain systems in a validated state.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.

Benefits

A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options
Company-Provided Life and Accidental Death Insurance
Short and Long-Term Disability Insurance
Retirement Plan including a generous non-discretionary employer contribution and employer match.
Adoption Assistance
Wellness Programs
Employee Assistance Program
Commuter Benefits
Various voluntary benefit offerings
Discount programs
Parental leaves