Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
50% Performance and reporting of safety testing for product release, and other related testing.
10% Compilation and entry of environmental monitoring data. Reviewing of EM Data
15% Recording and reviewing of daily monitoring data for laboratory equipment.
15% Assisting in raw material inspections by performing microbiological testing as required
5% Performing the required testing for protocols.
5% Revising of Standard Operating Procedure (SOP) as required.
Education/Experience: (Indicate minimum levels required.)
Knowledge and experience in the following areas is required:
- 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.
- 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
INTERNAL AND EXTERNAL WORKING RELATIONSHIPS:
- Requirements include following gowning procedures, usually lab coats, gloves and sleeves.
- The working environment includes working with chemicals such as strong acids and bases and will also involve exposure to human tissue products.
The above statements are intended to describe the general nature and level of work being performed by associates in this position. This is not intended to be an exhaustive list of all responsibilities and skills required.
- 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 is an Equal Opportunity and Affirmative Action Employer
Shire - 2 years ago
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