Position 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.

　　Key Responsibilities:

　　Review and maintain product compliance specifications, documentation control.

　　Gain proficiency on all testing areas.

　　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.

　　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.

　　Performs routine environmental monitoring and critical utility sampling.

　　Performs routine microbiology assays.

　　Participate in achieving department goals.

　　Support all company policies.

　　Performs other duties as assigned.

　　Minimum Requirements/Qualifications:

　　High School Diploma/ GED required.

　　Execute Stability Study testing in accordance with QA requirements.

　　Familiarity with FDA regulations for medical devices preferred.

　　Possess the ability to manage many tasks and in an organized fashion.

　　Able to communicate effectively with a variety of departments regarding 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 in English.

　　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 teamwork spirit.

　　Excellent verbal and written skills in English

　　Preferred Requirements:

　　Preferred someone studying towards a Bachelor’s degree in the biological sciences.

　　Some knowledge or schooling of course work in microbiology with a laboratory or a Bachelor’s degree with 5+ years of microbiology lab experience.

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.