Quality Assurance Professional

Company: Cortech
Location: Lincoln
Posted on: January 11, 2021

Job Description:

$15-18/hr - depending on education and experienceQuality Coordinator (Incoming Material Inspection)Hours: 7:30 am - 4:00 pm; Monday - Friday (1st Shift)Cortech is seeking to hire a qaulity assurance professional for our client in Position Responsibilities--- Compile documents and supporting documents for biological and pharmaceutical raw material receipts--- Perform preliminary review of documentation and specifications--- Update controlled documents (internal and registered) as needed to support area functions--- Update SOP's (standard operating procedures) and related documents as needed to support the Quality Operations Team--- Raw material sample handling and archival--- Perform back-up admin duties.--- Verify and record results and/or disposition in the laboratory information management and enterprise resource planning (LIMS/ERP) systems--- Collect/track documentation requested during audits.--- Assist with other activities as requested, including, but not limited to use/support of Quality Systems (both Quality Tracking and Laboratory Information Systems)support of annual product review, risk assessments, change control, supplier management, stability program--- Perform other duties and special projects, as assignedEducation and Experience2 year Associates degree in Chemistry, Biology or related field or equivalent post-secondary education or a minimum of 2 years relevant work experience with material disposition, laboratory testing, LIMS or MRP/ERP computer systems and/or regulatory documentationExperience with incoming inspection of raw materials within the Pharmaceutical industry preferred.Technical Skills and CompetenciesRequired Candidate Qualifications:--- Some working knowledge of US-FDA, EU and International Registration requirements--- Demonstrated strong technical systems skills--- Proficient in Word and Excel Microsoft applications--- Strong organization skills with proven experience in multi-tasking and prioritizing projects--- Process and detail oriented with the ability to follow complex processes and prepare detailed structured documents--- Demonstrated organizational and administrative skills and the ability to communicate effectively with multiple organizationsPreferred Candidate Qualifications:--- Experience in change management processes, manufacturing/quality operations, laboratory and/or regulatory affairs--- Experience with Training Documentation Systems, Quality Tracking Systems, Laboratory Information Management and Manufacturing Resource Planning Systems (SAP), Microsoft Office applications

Keywords: Cortech, Lincoln , Quality Assurance Professional, Other , Lincoln, Nebraska