Supervisor, Quality Assurance

1 week ago

Oklahoma City, OK, United States Alk Abello Full time
About ALK

ALK is a forward-thinking allergy company with a long tradition of allergy innovation. 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 with 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.

We are currently looking for a Full-time Quality Assurance Supervisorto join our teamin our Oklahoma City, OK facility.
The ideal candidate will be comfortable working in a fast-paced environment, can manage multiple projects at one time and feel comfortable taking the lead when necessary.

Area of Responsibilities

Quality Assurance 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. Ensure compliance within QMCS and EUF for QA. The Quality Assurance 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 and report global quality metrics
  • Assist regulatory with DMF updates as necessary
  • Oversee maintenance and reporting QA plant Metrics
  • Oversee Quality Systems Informational Packet in collaboration with Quality Assurance Floor Inspectors Supervisor
  • Review and approve relevant documents
  • Performing SAP functions as required
  • Assist in product and mock recalls as necessary; maintain contact list of distributors of OKCAS products
  • Review and oversee completion of observations and inspection cases in QAChange
  • Review customer complaint cases as necessary
  • Perform CMMS responsibilities as required
  • 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
  • Oversee product retention sample area
  • Oversight of QA responsibilities within QMCS and EUF
  • Completing supplier complaint forms
  • Oversee annual site GMP training
  • Responsible for overseeing incoming material quarantine, release, and rejection
  • 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
  • Other duties may be assigned
Competences

Competences required 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

Why ALK?

At ALK, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.

ALK offers:
  • Excellent benefits including medical, dental, and vision
  • Life and Disability insurance covered at 100%
  • 401(k) plan with generous employer contribution
  • 12 company-paid holidays per year
  • Pay Range: $60,000 - $75,000 annually

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.

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