QA Floor Inspector

ALK-Abello, Inc•Oklahoma City, OK

7d•Onsite

About The Position

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. Since 1923, we have been working to improve the quality of life for allergy patients by developing products that target the cause of allergy. With over 2,200 employees and subsidiaries, production facilities and distributors worldwide we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on NASDAQ OMX Copenhagen (OMX: ALKB) with global headquarters in Horsholm, Denmark and US Offices in Round Rock, TX, Bedminster, NJ, Port Washington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada. ALK has an opening for a full-time QA Floor Inspector (Late Shift), located in our Oklahoma City, OK facility. Area of Responsibilities QA 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.

Requirements

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.

Responsibilities

Timely creation and issuance of batch records
Approximately 40% of shift spent on the production floor working with manufacturing to ensure products produced meet SQuIPP
Verify daily cleaning is complete prior to production setup
Verify REES (non-viable monitoring system) is within proper limits and visible for Line 2 technicians prior to production setup
Discuss any errors directly with production personnel so corrections can be made; Collect data on errors and provide to manufacturing management for trending/process improvement purposes
Performs in-process inspections of active production, filling, labelling and packaging areas to resolve problems early and to ensure compliance with SOP and regulatory requirements
Provide 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 events
Consistently reviews in-process batch documentation to ensure real-time compliance to product specifications, good documentation practices, company SOP’s and cGMP’s
Participate and oversee media fills
Assemble media fill batch record.
Reviews Production logbooks for accuracy and compliance
Perform daily pressure checks to ensure within proper limits prior to production setup
Perform quality assurance responsibilities involving environmental monitoring
Review and author relevant documents
Author and review relevant deviations, change cases, quality acts, etc
Participate in health authority inspections, customer audits, and global quality audits
Follow area SOPs and WINs
Document work according to established SOPs
Participate and hold company meetings
Other duties may be assigned