Specialist I, QC Data Reviewer

1. JOB SUMMARY

Responsible for generations, tracking, and completion of quality investigations and compliance records for the QC department. Performs review of in-process, release, and stability testing data to support a GMP facility and manufacturing.

2. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Assesses compendial changes; leads change for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Provides review and feedback to developmental labs in support of analytical assay development, transfer and qualification/ validation studies to meet regulatory and ICH guidelines.
• Assists with execution, documentation and review of testing as required to support product release, stability, and validation studies.
• Leads or coordinates complex projects with other departments and interacts with other department personnel to accomplish objectives.
• Leads LIR, OOS, and QC based deviations investigations; designs and implements corrective action plans to address deficiencies.
• Ensures the reliability and accuracy of the computer databases, and paper files.
• Writes proposals and/or summary documents suitable for external distribution or for regulatory submission that collaborate data from multiple sources.
• Provides technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments as a member of a cross-functional team.
• Provides information in support of department budget. Contributes to departmental strategy and provides input on lab requirements and improvements.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree in chemistry, biology or related field of study.
• Minimum of five years directly related experience in the pharmaceutical/biopharmaceutical or related industry.
• Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
• Proficient and professional communicator, verbally and in writing.
• Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
• Strong organizational and interpersonal skills and the ability to work collaboratively with others.
• Proficient in complex procedures and problem solving.
• Strong commitment to teamwork, proven leadership skills, independence and initiative.
• Extensive knowledge of biomolecular analysis; practical experience with a range of analytical instrumentation / methodology including such methodologies as FTIR, GC, HPLC, ELISA, immunological assays, spectrophotometric analysis, USP/EP testing, wet chemistry.
• Proficient in Microsoft Office - Word, Excel, PowerPoint.
• Comprehensive knowledge of pharmaceutical GLPs and GMPs.
• Comprehensive knowledge of laboratory techniques and safety precautions.
• Comprehensive knowledge of regulatory/industry guidance.

4.  PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.