Quality Lab Assoc II

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
1) Conduct critical biological, chemical and physical analyses on raw materials, initial, in-process and final products, and samples collected from the environmental monitoring programs at manufacturing facility.Work under minimum supervision.
2) Serve as Mentor to Quality Laboratory Associate (QLA) I positions. Provide training and work direction for QLA I positions as required.
3) Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.
Use sophisticated laboratory instrumentation and computer systems to collect and record data.
4) Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.
5) Complete all testing, including special project / protocol testing in a timely and appropriate manner.
6) Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
7) Investigate deviations and write exception documents.
8) Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
9) Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.10) Perform equipment maintenance and calibrations as required.11) Ensure timely release testing of in-process and finished products.12) Write, revise and review SOP's13) Perform/assist in internal assessments by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Maintain expertise in quality systems and quality techniques.14) Maintain a high level of expertise in current regulatory requirements and technical issues. Participate in QA/QC multi-site projects in the role of contributor, coordinator or leader.15) Assist in training staff and assures training requirements are met and records are up to date. Assists and writes validations for equipment, product changes and computer systems.16) Assists with vendor audits/assessments and provides ongoing feedback related to quality issues.17) Liaison between suppliers and customers, often interfacing with customers from around the world.18) Perform essential Microbiology functions such as in-process bioburden testing, microbial identification, gram stain, frozen cultures, growth promotion, sterility testing, environmental monitoring, monitoring of critical systems.Qualifications
1) Proficient in wet and instrumental methods of analyses.
2) Advanced laboratory skills, basic knowledge of statistical method.3) Strong technical problem solving skills.
4) Ability to handle multiple tasks concurrently, and in a timely fashion.5) Computer literate.6) Must be able to communicate effectively with supervisors and peers.
7) Must demonstrate effectiveness in ability to train others, empowerment, leadership, results orientation and task completion.8) Bachelor Degree in Microbiology, Biology or related scientific discipline. Previous relevant experience desired (3-5 years in Quality Assurance or QC/QA analysis).9) Exceptional organizational skills and ability to plan and implement resolutions to technical problems. Familiarity with auditing techniques, interpreting regulations and quality systems.10) Understand scientific strategies and be able to invent new methods or new avenues of investigation.11) Good interpersonal/communication/influencing/negation skills.12) Good project management skills.13) Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V
REQUIREMENTS
Please see Job Description