Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
QC Specialist II: The purpose of this position is to perform technical activities that support data and method performance trending, method validation, and method transfer. This position will require strong technical writing skills and will be the technical liaison with Research and Analytical Development departments. This position will work closely with other QC Specialists to ensure that current and transferred methods are performing accurately and precisely.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
EDUCATION and/or EXPERIENCE BS degree in a Biology, Chemistry or equivalent QC related field and 5-8 years' experience in a GMP or similarly regulated environment such as a pharmaceutical drug manufacturing, biologics or biotechnology company.
- Design studies in accordance with the corresponding regulatory and ICH guidelines , and generate test methods and validation and transfer protocols and reports
- Execute and/or oversee method validation and method transfer studies; conduct statistical analysis, as applicable. Act as liaison with the Analytical Development department and review method qualification reports
- Train QC staff on new test methods and assist with method troubleshooting
- Assess method performance via routine trending; issue method trending reports
- Assist with statistical analysis and trending of QC product release, method control / standard, and stability data.
- Perform release testing, as assigned. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Must also possess the following qualifications: • In-depth knowledge of cGMP, GLP and FDA regulations and compendial requirements for drugs, biologic and biotechnological products • Proven record with overseeing/executing successful method validation studies • Proficient with statistical analysis for complex biological assays
LANGUAGE SKILLS Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries from regulatory agencies, other departments, and outside vendors. Ability to effectively present information to top management.
- 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 written and verbal communication skills.
- Familiarity with handling OOS, retest and assay validation requirements. • Experience coordinating team and / or individual projects.
- Strong background in testing techniques, such as ELISA, cell biological, immunological, colorimetric and spectrophotometric techniques.
MATHEMATICAL SKILLS 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.
REASONING ABILITY 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.
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 is an Equal Opportunity and Affirmative Action Employer
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