Aerotek QC Documentation Specialist in Baltimore, Maryland
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.
quality assurance, Investigation, deviations, technical skills, gmp, Document control, investigations, deviation, technical writing, SAP, QA
Top Skills Details:
Additional Skills & Qualifications:
• 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.
• 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.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.