The major purpose of this position is the performance and reporting of analytical testing for product release. In addition, this position participates in testing activities related to failure investigations and method qualification / validation. The QC Analyst I position ensures that the company goals for timely product testing are accomplished by being directly involved in the generation of test results for product release and investigations
90% Lot Release Testing
5% Validation / Qualification Testing
5% OOS / Lab Investigation Support Activities
Education and Experience Requirements
BS degree in a Biology, Chemistry or equivalent QC related field and 0-3 years’ experience in a GMP or similarly regulated environment such as a pharmaceutical drug manufacturing, biologics or biotechnology company.
Key Skills, Abilities, and Competencies
• A detailed knowledge of cGMP, GLP and FDA regulations and compendial requirements for drugs, biologic and biotechnological products
• Proficiency with the computer software necessary to perform data handling tasks as well as accessing e-mail and filing out timesheet reports. (Microsoft Excel, Word, Outlook and Access)
• Good communication skills both written and verbal
• Familiarity with handling OOS and retest requirements
• Strong background in testing techniques, such as ELISA, cell biology, immunological, colorimetric, and spectrophotometric techniques.
Complexity and Problem Solving
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Internal and External Contacts
This position requires the ability to coordinate with internal personnel from Incoming Inspection, Quality Assurance, Quality System, Distribution, and Material Receiving groups.
Other Job Requirements
Requirements include following gowning procedures, usually lab coats, gloves and sleeves (85%)
The working environment includes working with chemicals such as strong acids and bases and will also involve exposure to human tissue products.
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 plc (Shire) is a specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its...