Job Details:
The Quality Control Associate will be responsible for receiving, sampling, testing, analyzing, recording and reporting results of analytical tests of pharmaceutical materials, as well as providing overall support for lab functions as a member of the Sentry BioPharma Services Quality group.
Duties & Responsibilities:
- Receive, label, and safely store samples to be tested.
- Perform aliquoting from bulk containers to obtain test samples.
- Organize and store samples in accordance with all safety and other requirements to ensure the safety of personnel and integrity of the sample.
- Prepare samples prior to testing.
- Set up, calibrate and troubleshoot equipment to ensure accurate testing.
- Prepare lab equipment for upcoming analyses.
- Perform analytical tests on materials samples or assist other laboratory employees in performance of testing.
- Perform laboratory testing according to compendial and standard testing methods, recording observations, and interpreting findings.
- Record all experimental data and test results accurately and in the specified format (written and/or electronic).
- Manage, analyze, and report test data; compile results of analytical testing into graphs, documents, and reports.
- Maintain daily logs and equipment record books.
- Maintain lab records and quality control programs.
- Perform quality-control checks and audit lab logbooks to ensure following of proper procedures.
- Clean and maintain lab equipment, including recalibration of equipment.
- Keep equipment in proper working order by following operating instructions, troubleshooting breakdowns, maintaining supplies, performing preventive maintenance, and calling for repairs.
- Maintain inventory and assure availability of supplies, materials, and equipment needed for laboratory.
- Order, receive, and store needed supplies, materials, and equipment.
- Coordinate budgetary requisitions and expenditures for laboratory supplies and equipment, repairs, alterations, preventative maintenance contracts, and purchase orders.
- Control expenditures within the assigned budget allocation; and provide data for and prepare budget estimates.
- Generate purchase orders for needed supplies, materials, and equipment.
- Organize and store all chemical reagents, solvents, and other laboratory supplies in compliance with state and local laws and regulations relating to health and safety, and safe storage and disposal of hazardous materials.
- Organize and facilitate the collection, clean up, and disposal of biohazardous or toxic chemical waste; interface with hazardous waste disposal vendors.
- Support laboratory staff by cleaning, maintaining ordering, receiving and inventorying glassware.
- Manage cleanliness and orderliness of the lab and analytical instruments ensuring overall laboratory integrity.
- Practice safe work habits, including complying with all safety, health, and environmental rules and regulations.
- Maintain the laboratory in a safe, clean, and orderly condition, which includes functional checks on safety equipment such as eyewash stations, showers, fire extinguishers and hoods.
- Support other laboratory employees by troubleshooting and resolving problems and helping with special projects.
- Complete projects by assisting project team and attending and participating in group and project meetings.
- Update job knowledge by participating in educational opportunities and staying current on technical and scientific advances in the field.
- Maintain regular work attendance.
- Perform additional duties as assigned by supervisor/manager.
Competencies:
- Excellent attention to detail and organizational skills.
- Excellent verbal and written communication skills.
- Ability to write correspondence and reports.
- Ability to keep detailed, accurate, and complete records.
- Detail-oriented, focused, able to follow instructions and strictly follow procedures.
- Meticulous and organized, with the ability to multi-task.
- Motivated and capable of self-development.
- Excellent critical thinking and problem-solving skills.
- Ability to work independently and within a team.
- Ability to work autonomously and under pressure.
- Effective time management when dealing with and working under time constraints and other pressures associated with performing all aspects of the job.
- Superb dexterity and hand-eye coordination.
- Previous experience working in a laboratory setting.
- Knowledge of standard analytical chemistry methods and lab equipment.
- Meticulous and cautious, able to prepare test samples without contamination or errors.
- Highly organized and systematic creating an organized, reliable and uniform testing environment producing consistent results.
- Knowledge of analytical equipment operation, basic maintenance, and calibration.
- Relevant computer, mathematics, and science skills.
- Understanding of electronic and computerized equipment in laboratories.
- Knowledge of data analysis applications.
- Knowledge of and ability to strictly observe laboratory and biohazard safety.
- Comfortable handling potentially dangerous substances (flammable liquids, biohazards, etc.)
- Supply management skills.
- Knowledge of GMP regulations and reporting requirements.
Education and/or Experience:
- Bachelor’s degree in biology, chemistry, or a related field.
- Preferred experience working in an analytical laboratory.
- Work doing pharmaceutical analyses, and/or analysis of large molecules, a plus.
- Experience may substitute for education, if adequate
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Location: Columbus, IN
Department: Quality Assurance
Schedule: Full Time, On-Site
Experience: Working in Analytical Laboratory
Education: Bachelor’s Degree in Biology, Chemistry, or Related
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