Quality Technician
Location:
Posted:
November 23, 2016
Reference:
5009B9


Description
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Perform operations to support analysis of pharmaceutical products (biologics and drugs) in the QC Laboratory. Tasks support functionality of the department; however, required activities will not generate data necessary to evaluate or support product quality.

• General laboratory housekeeping.
• Cleaning of laboratory glassware and equipment.
• Preparation of material for sterilization in the QC Laboratory Autoclave.
• Operation of equipment preparation and cleaning systems in QC (e.g. QC Laboratory Autoclaves, (QC glasswashers).
• Maintenance and stocking of departmental consumable inventory.
• Routine verification of operating parameters of temperature controlled units.
• Routine cleaning and maintenance of temperature controlled units.
• Set-up and disinfection of media, supplies, and equipment needed for testing.
• Perform sampling of critical utilities systems (e.g. water, air, alcohol).
• Perform non-batch release testing (e.g. raw materials, environmental monitoring)
• Assist in filing and archiving of departmental data, binders, reports, investigations, etc.
• Assist in retrieval of samples from manufacturing areas to the QC Laboratory for testing.
• Ensure laboratory area is maintained in a GMP state at all times while following all EHS and 6S guidelines. Areas must be suitable for hand off to oncoming shifts
• Maintenance and disposal of waste generated throughout the laboratory.
• Support sample control as needed.
• Ensure personal training requirements are met and that training records are current.
• Other duties as assigned by management.

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Qualifications

• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Computer literate and competent with a general knowledge of word processing and spreadsheets (such as Microsoft Office).
• Must be detail oriented, conscientious and have a good reading comprehension skill.
• Laboratory experience preferred
• Must have effective verbal and written communication skills
• Must be able to understand and apply cGMP/GPD, follow SOPs, and meet EHS requirements

• Must understand basic math and science

High School diploma or equivalent required. College coursework in Microbiology, Chemistry, or biological science preferred. Previous relevant experience desired

• Must be able to lift, push, pull and carry up to 25 lbs
• 20/20 near vision required (corrected vision is acceptable)
• Must be able to recognize and distinguish among the colors red, yellow and blue.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas
• No contact lenses may be worn in the work environment. No make-up, jewelry, nail polish or artificial nails may be worn in the work environment when applicable.
• In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.

• Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
• May be required to work or be assigned to a different shift to meet business needs. Must be willing to work off shift hours.
• Must be able to work supplemental hours as necessary to complete work commitments.
• May be required to work in a confined area.
• Primarily inside working conditions.
• Some clean room and cool/hot storage conditions.

Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy
Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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