Job Title: Quality Lab Associate Location: Round Lake, IL 60073 Duration: 12 months
Shift: 3rd Hours: 4 10-hour shifts (Sunday to Thursday 10 pm to 8:30 am)
Summary: The Position encompasses the biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods, and environmental monitoring programs. This is a third shift position but will be required to work on weekends to support training of analysts and to support projects and/or production, as required. A candidate must not be allergic to Penicillin and Cephalosporin or their related products and /or materials.
Essential Duties and Responsibilities: • Conduct critical chemical and physical analyses on Raw Materials, Initial, In-process and Final products, and samples collected from environmental monitoring programs at manufacturing facilities. Work under minimum supervision. • Use sophisticated laboratory instrumentation (HPLC, FTIR, UV, GC etc) and computer systems to collect and record data. • Perform advanced assays requiring precise analytical skills and understanding of biology and chemistry principles. • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. • Participate in functions 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. • Perform equipment maintenance and calibrations as required. • Document the completion of testing in Notebooks, Controlled documents, Forms and LIMS and maintain accurate and complete quality records. • Follow, understand and comply with SOP’s and policies on cGMP’s and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas. • Investigate deviations and write exception/OOL/OOS/OOT documents. • Support improvement projects and drive efficiency through utilization of LEAN management principles (i/e/ 6S, Kaizens etc). • Proactively and cooperatively communicate with peers and management to ensure awareness of progress and issues; recommend solutions when issues arise. • Maintain and meet the highest standards in quality, customer service and regulatory compliance. • Other projects as assigned. Qualifications: • Knowledge of Empower CDS and LIMS is preferred but not required • Knowledge of GLP, cGMP requirements and familiar with USP/ICH guidelines is preferred but not required • Excellent communication (oral and written) and interpersonal skills • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude in a highly dynamic environment • Ability to lift up to 50 pound when required • Occasional weekend work required • Must not be color blind
Education and/or Experience: • Bachelors degree in Chemistry or Science related degree with 6 months or more of experience
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $25.00/hr.
