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Ability to interface with clients as required.
2+ years relevant experience required
Outstanding communication skills, understanding of cGMP regulations and knowledge of investigation techniques including root cause analysis (RCA) and technical writing skills are required.
Skill in communication, written and verbal.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ability to read, analyze, and interpret industry-related periodicals, SOPs, and government regulations.
Knowledge of Good Manufacturing Practice (GMP) guidelines as well as international regulations (i.e., International Conference on Harmonization (ICH) Q7) pertaining to the production of Active Pharmaceutical Ingredients (API) and drug products.
Ability to lead cross-functional teams.
Knowledge of and skill in using computer software and hardware applications, including Microsoft products and the internet, are required.
Actively lead or participate in the investigation of major QC laboratory investigations including providing technical assistance to Quality Assurance (QA) on the final product impact assessment and identification of root cause.
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
Bachelor's degree in chemistry, biology, engineering or related life science field; or an equivalent combination of education and related experience.
Have the training and ability to participate in and/or lead investigations applying scientific methods and effectively present findings and solutions to customers, co-workers, or members of management.
Skill in managing various projects; must be able to use individual discretion in completing work assignments while assisting the group in establishing priorities, setting standards and working collectively to accomplish deadlines and objectives.
Requires in-depth knowledge and experience in job and ability to work independently
Ability to write reports, business correspondence, and procedures.
Ability to respond to common inquiries, comments or complaints from customers, co-workers, subordinates, and supervisors regarding the documents, products and processes.
Able to identify personnel and documentation to support knowledge of equipment and processes utilized to analyze materials used in production of APIs such as, but not limited to: raw materials, in-process samples, and API/DP.
Computer skills, especially with Microsoft Word, Excel, Visio are preferred.