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21 Alaya Bioscience Inc Jobs

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Quality Specialist (Bioscience)

Latitude, Inc.
Rockville, MD 20847
Full-time, Part-time
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Job Description

Job Description

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.

ADDITIONAL INFORMATION:

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.

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Posting ID: 608955937Posted: 2021-03-03