Quality Control/Testing

Quality Control/Testing

  Not Disclosed

  Durham , NC

  6.0 Months

  Not Disclosed

  Not Disclosed

  Healthcare

Job Description

Description:
Position Summary

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.

Primary Duties
1) Leadership

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

2) Quality

a) Ensures all testing documentation is completed in an accurate, thorough, and timely manner. Documents test results in compliance with procedures and GDP requirements.
b) Ensures review of laboratory testing is done in compliance with SOPs and is completed in a timely manner.
c) Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
d) Prepares for regulatory, customer, and internal audits of Biochemistry laboratory areas.
i) Preparation includes review of logbooks for completion, instrument calibration checks, checking material expirations, and general cleanliness of laboratory area.

e) Executes laboratory investigations as assigned by management in compliance with procedures.

f) Provides input for laboratory investigations and documents invalid test results in compliance with procedures.


3) Documentation/Training

a) 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.
b) Assists with revisions to QC department standard operating procedures (SOPs) as directed by management.
c) Ensures personal training is maintained to current department processes and procedures.
d) Trains teammates on Biochemistry laboratory testing and procedures.
e) Obtains status as a certified trainer for applicable laboratory testing processes.

4) Safety

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

5) Continuous Improvement

a) Participate in continuous improvement activities.

i) Participate in improvement initiatives as directed by management.

b) 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner at all times, in compliance with cGLP.

6) Other Duties

a) 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.

b) Performs additional job-related duties as assigned by management.

Supplemental Data
This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry Analyst 2 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.


Experience
1. BS with minimum 2 years of experience, or a Master’s degree or PhD with 0 years of experience, in a regulated laboratory environment, Chemistry or Biochemistry is highly preferred.
2. Technical and scientific knowledge working with relevant chemistry or biochemistry laboratory techniques and quality principles (GMP/GLP).
3. Experience in the use of software tools for data entry and analysis (LIMS); advanced technical writing skills.
4. In depth knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.).
5. Experience participating in the management of regulatory audits (i.e. FDA, MDSAP, ISO, OSHA, EPA, etc.).
6. Experience with chemistry or biochemistry testing, knowledge of USP and EP/BP method/validation regulations.
7. Experience with applicable instrumentation and troubleshooting.

Knowledge, Skills, and Abilities
Strong organizational skills, the ability to prioritize work and manage multiple tasks independently.
Excellent and effective verbal and written communication skills.
Proven ability to problem solve/troubleshoot and provide solutions under minimal supervision.
Good leadership and 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.

In lieu of a Bachelor’s Degree, a high school diploma/GED with a minimum of = 6 years of experience and/or an Associate’s Degree with a minimum of = 4 years of experience working in a regulated laboratory environment, Biochemistry or Chemistry is highly preferred.