We are expanding our Early Development (ED), Bio Analysis (Large Molecule) Group and looking for talented QC Reviewer with solid experience in GLP regulation.
Essential Job Duties:
- Reviews study documentation and laboratory records.
- Reviews study compliance against protocol, SOP, and regulatory agency guidelines.
- Informs Study Director, Principal Investigator and/or management of any problems and/or deviations that may affect the integrity of the data and recommends corrective actions.
- Participates in process improvement initiatives. Provide suggestions for changes in experimental process to improve efficiency of daily/routine procedures and compliance with regulatory agency guidelines, as applicable.
- Assure technical staff compliance to SOPs and other regulatory agency guidelines
- Performs QC review of data.
- Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, including scheduling and leading meetings as required.
- Responsible for reviewing and monitoring process of experiments, including documentation, SOP and/or regulatory guidelines compliance.
- Assists in interpreting and evaluating data for incorporation into written reports.
- Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
- Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
- Prepares for and participates in routine client visits.
- Manages data transfer to clients as requested.
- Assists SD/PI in monitoring study phases.
- Assists with training and mentoring less experienced staff.
- Assists in writing SOPs
- Maintains an awareness of the financial status of ongoing studies.
- Performs other related duties as assigned
Education / Qualifications*
- BS/BA degree in science plus at least 4-5 years experience or MS degree with 2-4 years experience.
- Efficient use of word processing software, database, spreadsheet, and specialized software.
- Proficient in concise writing. Writing should require little or no external review or edit.
- Adherence to grammar, punctuation, composition, and spelling according to company standard conventions.
- Experience on a variety of studies performed in the department and exposure to a diverse client base.
- Knowledge of regulatory agency guidelines.
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.
There is no better time to join us!