Job Description
~ Seeking motivated science individuals who are looking for opportunities with one of our larger clients in the Twin Cities Area. This role offers competitive pay and opportunities for growth in a team-oriented environment ~
Description:
The QA Analyst will conduct biological, chemical and physical testing on pharmaceutical products (biologics and drugs) and medical devices in a GMP lab through all stages of manufacturing process from incoming raw materials to finished goods and may include some environmental monitoring programs.
Key Responsibilities:
- Conduct critical biological, chemical and physical analyses such as raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at manufacturing facilities, etc.
- Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS system). Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
- Complete all testing, including special project / protocol testing in a timely and appropriate manner.
- Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
- Write exception documents.
- Participate in functional efforts involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
- Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.
- May perform equipment maintenance and calibrations as required
Skills & Qualifications:
- BS/BA in Microbiology, Biology or Chemistry or like field
- Must have an understanding of aseptic techniques, or biological testing (college courses are fine)
- Attention to detail, with ability to keep detailed notes and logs.
- Micro tests knowledge to understand what we are testing for: endotoxin testing, aseptic techniques, bio-burden testing, sterility testing
- Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
- Proven ability to navigate computer systems including Word, Excel, etc
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 ActalentActalent 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.