Latitude, Inc. Quality Specialist (Bioscience) in Rockville, Maryland
QUALITY SPECIALIST II ? OPERATIONS
The Quality Specialist II ? Operations is responsible for independent, Quality Assurance oversight governing the following systems in support of GMP product manufacturing including Material Specification and Batch Record approval, Batch Record Review, Product and Material Release, Quality On-The-Floor, Process Deviations and Client Support.
The main responsibilities will include but not limited to follows:
Critically review, approve and issue various GMP documentation to ensure completeness, accuracy, and compliance; including but not limited to: manufacturing records, Quality Control Environmental Monitoring data, batch and material release, specifications, SOPs, alarm reports, deviation investigations, CAPAs and change controls. Perform Quality on the floor responsibilities during production Room, Product and Material Release Independently review and perform disposition of raw materials, components, cell banks and client materials. Provide QA representation on projects with clients Support Lot Release Activities Review Standard Operating Procedures in document management system Building Alarm Response and Trending Material Movement and Shipment Provide QA representation for Facility Shutdown activities Label inspection Pest Control Review Exercise judgment within defined Quality Assurance and Manufacturing procedures to determine appropriate action for resolution of manufacturing issues Participate in audit plans and activities and serve as subject matter expert in quality assurance operations Train other team members Comply with Quality Systems including but not limited to Deviations, CAPAs, Change Control, and Management Review in support of manufacturing operations Lead or participate in cross-functional teams to address facility issues using methodical problem solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product Prepare functional and Management Review metrics for identification of negative trends. Other duties as assigned.
Knowledge and Experience Required:
Bachelors of Science Degree in Biology, Chemistry, Engineering, or related fields A minimum of 4 years? experience in a cGMP environment is required. Lean/Six Sigma experience, or equivalent certification/education/experience preferred Prior experience with US and EU pharmaceutical regulations Knowledge and application of cGMP principles, and working in an FDA regulated environment Excellent communication skills: oral, written and listening Critical analytical skills Ability to work under pressure and analyze processes within scheduled timeframes Ability to work independently or with little guidance Previous experience in a CMO or CRO is a plus Previous experience with the implementation and use of electronic quality management systems. Ability to manage multiple projects simultaneously. Must be a team player and able to interact with all levels of our staff and Management. Excellent computer skills; strong knowledge of MS Office, Excel, Word, Power Point, Outlook, Visio Serves as a change agent for continuous improvement within the scope of work. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Determines methods and procedures on new assignments with input from subject matter experts, and may coordinate activities of other personnel.
Candidate must meet all the requirements of our Company Occupational Health program as directed by the Occupational Health Consultant to include pre-employment physical and drug screen.