QC Biochemistry Analyst - LanceSoft Inc
Durham, NC 27712
About the Job
Shift timing : 7pm-7:30am on a rotating 2-2-3 (two days on, two days off, three days on) Nights/Rotating Schedule
Job Description
Position Summary:
Responsibilities:
Quality
Documentation/Training:
Safety:
Continuous Improvement:
Other Duties:
Supplemental Information:
Training and Education:
Experience:
Knowledge, Skill, and Abilities:
Job Description
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:
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 Biocehmistry laboratory areas.
- Preparation includes review of logbooks, instrument calibration dates, material expirations, and general cleanliness of laboratory area.
- 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.
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.
Safety:
- Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine laboratory duties.
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.
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. . The 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.
- A 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.
- Ability 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.
- Able to assess safety and environmental risks to ensuring tasks adhere to HSE Management System.
Source : LanceSoft Inc
