QA Floor Inspector

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 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.

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

Competences

Competences 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.

ALK 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-time

Benefits: Health insurance, Dental insurance, Vision insurance, Retirement plan, Paid time off, Tuition reimbursement

This Company Describes Its Culture as: Detail-oriented -- quality and precision-focused, Outcome-oriented -- results-focused with strong performance culture, People-oriented -- supportive and fairness-focused

This 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