The major purpose of this position is the performance and reporting of microbiological testing for product release as well as environmental monitoring of all areas of the manufacturing facility, water sample collection and testing, compilation and entry of environmental monitoring data The position ensures that the company goals for timely product testing are accomplished by being directly involved in the production of test results for product release and investigations. Other responsibilities or tasks as deemed necessary from time to time by the area’s supervisor.
70% Environmental Monitoring program and perform safety testing for product release, and other related testing
10% Recording and reviewing of daily monitoring data for laboratory equipment
10% Performing the required testing for protocols
5% Compilation and entry of environmental monitoring data. Reviewing of EM Data
5% Revising of Standard Operating Procedure (SOP) as required
Education and Experience Requirements
AS or BS degree in a Biology, Chemistry or equivalent QC related and 1 or more years experience in a GMP or similarly regulated environment such as a pharmaceutical drug manufacturing, Biologics or Biotechnology company
Key Skills, Abilities, and Competencies
• Handling biohazardous materials and chemicals
• Basic laboratory safety procedures
• A detailed knowledge of cGMP and GLP regulations and compendial requirements
• Proficiency with the computer software necessary to perform data handling tasks as well as accessing e-mail and filling out timesheet reports. (Microsoft Excel, Word, Outlook and Access)
• Good communication skills both written and verbal
• Experience with in testing techniques such as Environmental Monitoring (EM), Bioburden, Endotoxin, Sterility, and Bacteriostatis/Fungistasis testing
Complexity and Problem Solving
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Internal and External Contacts
This position requires interaction with Manufacturing for obtaining product availability information and testing needs and interaction with Quality Assurance to obtain documents and Product Development and Research for troubleshooting and developing assays. Engineering and Facilities for equipment related issues.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
Shire is an Equal Opportunity and Affirmative Action Employer.
Shire - 13 months ago
Shire plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...