Mount Vernon, Indiana
Reports Coordinator-Research Facility Job Opening in Mount Vernon, Indiana - POSITION SUMMARY
This position is responsible for auditing raw data for compliance with Good Laboratory Practices (GLP) data recording regulations, study protocols and appropriate Standard Operating Procedures (SOPs).
RESPONSIBILITIES AND DUTIES
Quality Control Coordinator
Read, apply, and maintain adherence to GLP regulations, SOPs, and client protocols
Demonstrate basic understanding of GLP regulations and their implementation
Collate and organize raw data records into data books
Understand purpose and procedures of raw data forms
Responsible for auditing raw data for consistency, completeness and accuracy
Maintain a strong working relationship with the Quality Assurance (QA) Department
Provide input to management about process improvement
Provide additional QC data review support as needed
Participate in in-house training programs for the technical staff
Maintain confidential information
Interact with the community and employees
Support and participate in other company initiatives as directed by management
Perform other duties as assigned
Reports Coordinator
Work with various personnel to ensure reports are accurate and completed in a timely manner
Work with BASi Evansville Study Directors to implement the needs of each report
Be familiar with all types of data generated by the lab and be able to incorporate into the final report
Perform any report function as requested by Study Director or immediate supervisor
Keep abreast of information relating to government guidelines and specified sponsor requests
Generate special tables and analysis not performed by computer
Electronic formatting for individual reports
Data entry Participate in in-house training programs for the technical staff
Maintain confidential information
Interact with the community and employees
Support and participate in other company initiatives as directed by management
Perform other duties as assigned
REQUIREMENTS
Education / Experience:
Bachelor degree in related science (Chemistry preferred) with Quality Assurance/ Quality Control and/or Laboratory Animal Technician experience preferred.
Skills and Abilities:
Strong organizational skills, thorough and given to detail
A thorough knowledge of auditing
Ability to interact with other BASi staff at all levels
A working knowledge and awareness of general laboratory procedures
A thorough understanding of laboratory values and of a computerized database environment
Ability to work independently
Proven ability to perform accurate, concise documentation and to proof read documents accurately
Good written and spoken analytical skills
A clear understanding of Federal regulations, protocols, SOPs, and GLP/ GMP/ GCP
Ability to adhere to safety regulations and procedures
Good interpersonal communication skills
Good computer skills
TOOLS, EQUIPMENT, & OTHER RESOURCES USED
Various software applications sustained by a Windowsä platform. (Excel, Word, PowerPoint, etc.)
MasterControl, Watson LIMS, PDS
Microsoft Access, SQL, and/or Oracle databases
PERFORMANCE DEMANDS
Characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
General
Ability to read, write, speak and understand English
Ability to read, write and understand oral and/or written instructions
Physical Activity
This position will require frequent walking, sitting for extended periods of time, carrying, standing, heavy lifting (min. 50 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions.
Ability to walk over rough terrain
Working Conditions
Mantoux TB test with negative result is required
Able to wear latex or nitrile gloves, dust mask and/or respirator, and safety glasses as required.
The noise level is usually moderate
Job Type: Full-time
Required education:
Bachelor's
Required experience:
Quality Control: 1 year
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