QC Analyst - Microbiology

Position: QC Analyst - Microbiology
Location: 100 Rodolphe Street Durham NC 27712.
Duration: 6+ months Temp- to- hire.

Position Summary:

• The QC Biochemistry Analyst 1 role is responsible for routine Biochemistry testing. The responsibilities of this position include:
• Testing of raw materials, intermediates, special test requests, stability, and finished product per standard operating procedures.
• Investigational writing.

Responsibilities:
1. Quality

• 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.
• Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.
• Executes laboratory investigations assigned by management in compliance with procedures.
• Provides input for laboratory investigations and documents invalid test results in compliance with procedures.

2. Documentation/Training

• 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.
• Ensures personal training is maintained to current department processes and procedures.

3. Safety

• ppropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.

4. Continuous Improvement

• Participate in continuous improvement activities.
• 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.

5. Other Duties

• Performs additional job-related duties as assigned by management.

Supplemental Information:

• This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry.
• QC Biochemistry Analyst 1 will be in a key position in the Biochemistry laboratory performing testing of Description, pH, FTIR, Osmolality, Moisture Analysis, Solubility, Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC.

Training and Education:

• BS/BA in Biology, Chemistry, or Biochemistry with 0 years of relevant experience preferred.
• high school diploma/GED with a minimum of = 4 years of progressively responsible experience working in a regulated laboratory environment, GMP preferred and/or an associate's degree with a minimum of = 2 years of progressively responsible experience working in a regulated laboratory environment, GMP environment.

Experience:

• Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP) preferred.
• Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills preferred.
• Experience with microbiological testing, sterility and aseptic technique, knowledge of USP and EP/BP method/validation regulations preferred.

Knowledge, Skill, and Abilities:

• Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
• Excellent and effective verbal and written communication skills.
• bility to problem solve/troubleshoot and provide solutions under minimal supervision.
• Good communication skills; Teamwork orientation. Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility.
• ble to assess safety and environmental risks to ensure tasks adhere to HSE Management System.