QC Technologist

Job Description

Job Summary:

• Responsible for all quality control aspects of finished product testing.
• Ensure that performance of finished product is in compliance with testing standards per IFU and SOP’s in addition to customer requirements and regulating agencies’ guidelines.
• Documentation control duties per Quality assurance compliance requirements.

Duties and Responsibilities:

• Review and maintain product compliance specifications, documentation control.
• Perform and interpret microbiology testing including growth promotion, biochemical, AST.
• Product proficiency on all performance benches.
• Documentation of testing results and determining disposition.
• Maintain consistency in training in Master Control.
• Establish and maintain SOP criteria for inspection/testing.
• Responsible for maintaining department equipment and requesting consumables as needed.
• Exercise and monitor GMP compliance in work environment.
• Work closely with Quality Assurance department as a quality team.
• Execute Stability Study testing in accordance with QA requirements.
• Work in conjunction with Customer Service Representatives to achieve on time product releases for standing orders and special products.
• Work with the continuous improvement program within the department.
• Work closely with a team in a fast paced laboratory setting.
• Understand and exercise all safety requirements and procedures.
• Assists in maintaining standards in accordance with GMP’s/SOP’s and ISO regulations.
• Participate in achieving department goals.
• Support all company policies.
• Performs other duties as assigned.

Qualifications:

• Possess at least a 4 year degree in the biological sciences.
• Must have course work in microbiology with a laboratory or a 4 year degree with 5+ years of microbiology lab experience.
• A minimum combined 1-2 years of experience of in related QC/QA, microbiology laboratory work in a laboratory setting, or an equivalent combination of education and experience.
• Familiarity with FDA regulations for medical devices.
• Possess the ability to manage many tasks and in an organized fashion.
• Able to communicate effectively with a variety of departments in regard to quality testing parameters.
• Possess intermediate computer skills, preferably with experience in Microsoft word to include Word, Excel and PowerPoint programs.
• Experience working in SAP is a plus.
• Listen to, and follow, written and verbal instructions.
• Able to adapt and to learn new procedures and to maintain a scientific and objective approach.
• Must be available to work weekend shifts when needed.
• Self-motivated, highly responsible and possess a good team work spirit.
• Excellent verbal and written skills in English.

Non-Negotiable Hiring Criteria:

• Candidate must be a good time manager.
• Candidate must be willing to put in overtime when needed to complete tasks.
• Candidate must be a good team player/participant on teams.
• Candidate must have a high sense of responsibility.
• Candidate must possess critical thinking skills.