Job description
About ALK
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 Supervisor, QA Systems, located in our Oklahoma City, OK facility.
Area of Responsibilities
Quality Assurance Systems Supervisor responsibilities include overseeing quality systems of the OKCAS site, reviewing, approving, and authoring relevant GxP documents, Supervising the QA systems team and ensuring site compliance with EUF and QMCS requirements
- Oversee record retention and coordinate with relevant departments to ensure organization of document control area
- Maintain and report global quality metrics
- Review and approve relevant documents
- Review and oversee completion of observations and inspection cases in QAChange
- Review customer complaint cases
- Performing SAP functions as required
- Perform QCBD responsibilities as required
- Author, review, and/or approve relevant deviations, change cases, quality acts, etc.
- Assist in product and mock recalls as necessary; maintain contact list of distributors of OKCAS products
- Assume system administrator role for electronic document management system and QAChange
- Ensure timely completion of triennial reviews within the electronic document management system
- Oversee training management system
- Oversee training competency houses for OKCAS employees
- Assist regulatory with DMF updates as necessary
- Oversee product retention sample area
- Oversight of QA responsibilities within QMCS and EUF
- Completing supplier complaint forms
- Ensuring adequate and timely completion of direct reportee training
- Review, comment, and approve validation protocols
- 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
- Maintain personal development of reportees within relevant areas
- Backup to QA Manager for relevant responsibilities
- Assist in Corporate SOP implementation and maintenance of local documentation as necessary
- Other duties may be assigned
Competences
Competences 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 industry
ALK 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.
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
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