About this opportunity
ALK-Abello, Inc. lists this QA Floor Inspector opportunity in oklahoma city, Oklahoma. Review the employer’s description below for duties, qualifications and application requirements.
Job description
QA Floor Inspector (Late Shift)ALK is a forward-thinking allergy company with a long tradition for allergy innovation. We are making a bold move into digital to transform the way consumers, patients, and healthcare professionals address allergies. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.ALK has an opening for a full-time QA Floor Inspector (Late Shift), located in our Oklahoma City, OK facility.Area Of ResponsibilitiesQA Floor Inspector responsibilities include: working daily with production to ensure product meets SQuIPP, managing gowning qualification and media fill qualification programs, assisting with manufacturing investigations. The QA Floor Inspector must strictly follow quality standards and meet daily, weekly or monthly goals.Timely creation and issuance of batch recordsApproximately 40% of shift spent on the production floor working with manufacturing to ensure products produced meet SQuIPPVerify daily cleaning is complete prior to production setupVerify REES (non-viable monitoring system) is within proper limits and visible for Line 2 technicians prior to production setupDiscuss any errors directly with production personnel so corrections can be made; Collect data on errors and provide to manufacturing management for trending/process improvement purposesPerforms in-process inspections of active production, filling, labelling and packaging areas to resolve problems early and to ensure compliance with SOP and regulatory requirementsProvide real-time guidance to production personnel pertaining to compliance to cGMP's by monitoring dress code, documentation practices, etc.Perform approval of production rooms following maintenance or reduced gowning eventsConsistently reviews in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company SOP's and cGMP'sParticipate and oversee media fillsAssemble media fill batch record.Reviews Production logbooks for accuracy and compliancePerform daily pressure checks to ensure within proper limits prior to production setupPerform quality assurance responsibilities involving environmental monitoringReview and author relevant documentsAuthor and review relevant deviations, change cases, quality acts, etcParticipate in health authority inspections, customer audits, and global quality auditsFollow area SOPs and WINsDocument work according to established SOPsParticipate and hold company meetingsOther duties may be assignedCompetencesCompetences required to fulfil the area of responsibilities and work assignments:Education and Experience: Bachelor's degree or 2-4 years of Manufacturing and/or QA experience in the pharmaceutical industry.Must be able to work the 2:00 PM to 11:00 PM Shift. Shift differential will be provided.Salary: $55,000 - $62,000; 5% annual target bonusALK is an equal opportunity employer with competitive pay and excellent benefits including medical, dental, vision coverage, life and disability insurance, 401k plan with employer contribution, 12 company paid holidays per year, and up to 2 weeks' paid time off in the first year of employment with the company!Job Type: Full-timeBenefits: Health insurance, Dental insurance, Vision insurance, Retirement plan, Paid time off, Tuition reimbursementThis Company Describes Its Culture as: Detail-oriented -- quality and precision-focused, Outcome-oriented -- results-focused with strong performance culture, People-oriented -- supportive and fairness-focusedThis Job Is: A job for which military experienced candidates are encouraged to apply, A job for which all ages, including older job seekers, are encouraged to apply, Open to applicants who do not have a college diploma
Worksite address
oklahoma city, OK, 73101, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.