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 QC Analyst - Microbiology, located in our Oklahoma City, OK facility.
Peform and read Sterlity test on bulk and final products- Perform growth promotion and media release testing.
- Assist and perform environmental monitoring procedures.
- Assist and perform microbial water testing.
- Perform, assist or oversee sampling procedures for water for injection system.
- Perform endotoxin testing.
- Perform component receipt and release and any associated testing.
- Perform bioburden testing.
- Perform and enter raw environmental monitoring data in tracking and trending database.
- Perform testing of biological indicators.
- Review of documentation.
- Perform validations for all Microbiology test methods.
- Perform qualifications on Microbiology Lab equipment.
- Assist in Microbiology investigations
- Scheduled cleaning of equipment and lab
- Other duties as assigned by supervisor
- May require weekend work, holidays or overtime. Schedule must be flexible.
Competences
Competences required to fulfil the area of responsibilities and work assignments:
Education:
- Minimum High School diploma with technical degree in related field (vo-tech). College degree preferred in life science related field.
Experience:
- This position requires at least one year experience in a laboratory setting or College degree in life science.
- Knowledge of current Good Manufacturing Practices (cGMP), USP, FDA and ICH guidelines is preferred.
- The ideal candidate must be willing to be held accountable and must work well with others in order to ensure that all objectives are met on a regular and timely basis
- Excellent written and verbal communication skills
- Proficient in Microsoft Office applications, particularly Word and Excel
- Excellent laboratory technique and analytical skills manually dexterous
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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