Biochemistry Analyst I/II

Category:

Life Science

Employment Type:

Contract

Reference:

BH-384551

Biochemistry Analyst I/II

External ID # BIO180420252

Raleigh, NC- ONSITE

12 month W2 contract (with potential to extend or transition to perm)
Pay rate: Depending on Education and Experience

Analyst I - $22-24/hr
Analyst II - $26-28/hr

Summary:

The Biochemistry Analyst is responsible for routine Biochemistry testing.

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.

Responsibilities:
(Analyst II Includes duties of Analyst I and the additional specified)

• Testing of raw materials, intermediates, special test requests, stability, and finished product samples per standard operating procedures.
• Investigational writing.
• Provide input and support for Out of Specification reports. (Analyst II)
  

• Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP 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 as assigned by management in compliance with procedures.
• Provides input for laboratory investigations and documents invalid test results in compliance with procedures. (Analyst II)
  

• Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets.
• Provides input for laboratory investigations and documents invalid test results in compliance with procedures.
• Assists with revisions to QC department standard operating procedures (SOPs) as directed by management. (Analyst II)
  
• Obtains status as a certified trainer for applicable laboratory testing processes. (Analyst II)
  

• 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.
• Participate in improvement initiatives as directed by management. (Analyst II)
  

• Leads as trainer for Quality Control testing and instrument maintenance.
• Troubleshoots simple to moderate Biochemistry laboratory equipment related issues.

• 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.
• Ability to problem solve/troubleshoot and provide solutions under minimal supervision.
• Able to assess safety and environmental risks to ensuring tasks adhere to HSE Management System.

• In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards.
• Experience participating in the management of regulatory audits.
• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.
• Experience with applicable instrumentation and troubleshooting.

• BS/BA in Biology, Chemistry, or Biochemistry with 0 years of relevant experience required.
• Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations preferred.
• OR Associate's Degree with a minimum of = 3 years of experience working in a regulated laboratory environment, Biochemistry or Chemistry is highly preferred.
• OR High school diploma/GED with a minimum of = 5 years of experience working in a regulated laboratory environment, Biochemistry or Chemistry is highly preferred.

• BS/BA in Biology, Chemistry or Biochemistry with 2 years of experience in a regulated laboratory environment, Chemistry or Biochemistry is highly preferred.
• OR Master's degree or PhD with 0 years of experience

• Ability to remain in stationary position, often standing, for prolonged periods.
  
• Ability to ascend/descend stairs, ladders, ramps, and the like.
• Ability to wear PPE correctly most of the day.
• Ability to operate heavy machinery.
• Ability to adjust or move objects up to 50 pounds in all directions.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs