Supervisor, QA Operations - ALK-Abello : Job Details

About ALKALK 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, PortWashington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada.ALK has an opening for a full-time Supervisor, QA Operations, located in our Oklahoma City, OK facility.Area of ResponsibilitiesQuality Assurance Operations Supervisor responsibilities include ensuring training of direct reportees, metrics, review of investigations, change controls, CAPAs, batch records, validations. Ensure that all products manufactured conform to safety and quality standards. This ensures that shipped finished product fulfills all customer specifications and quality requirements. The Quality Assurance Operations Supervisor must strictly follow quality standards and meet daily, weekly or monthly goals.

• Oversee timely completion of APQRs
• Oversee record retention and coordinate with relevant departments to ensure organization of document control area
• Maintain Aseptic Process Simulation test kits
• Assist regulatory with DMF updates as necessary
• Oversee product retention sample area
• Maintain and report QA plant Metrics
• Update Quality Systems Informational Packet as necessary
• Ensure timely issuance and final release of batch records
• Oversee quality assurance responsibilities involving environmental monitoring
• Review and approve relevant documents
• Performing SAP functions as required
• Assist in product and mock recalls as necessary
• Author, review, and/or approve relevant deviations, change cases, quality acts, etc.
• Responsible for overseeing incoming material quarantine, release, and rejection
• Ensuring adequate and timely completion of direct reportee training
• Review, comment, and approve validation protocols, media fill reports, etc.
• Participate in health authority inspections, customer audits, and global quality audits
• Follow area SOPs and WINs
• Oversee annual site GMP training
• Document work according to established SOPs
• Participate and hold company meetings
• Maintain personal development of reportees within relevant areas
• Backup to QA Manager for relevant responsibilities
• Other duties may be assigned

CompetencesCompetences preferred to fulfil the area of responsibilities and work assignments:Education: Bachelor's degree in life sciences or related field.Experience: 3-5 years related experience in pharmaceutical quality assurance, biological drugs and/or the allergy industryALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.Pay Range: $55,000 - $75,000 annuallyBenefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday