Data Auditor

QC Data Auditor

Job Role Summary:

Location: Saint Petersburg, FL (ONSITE)

Contract: 8 months.

Specific Activities, and Responsibilities:

• Independently test, develop and implement assays useful for the identification and characterization of Raw Materials, pre-capsulation, Stability and Finished Products.

• Analyze data, perform statistical analyses, document results, maintain laboratory notebook according to cGMP and Internal guidelines.

• Communicate results in written and oral presentations.

• Write protocols, procedures and technical reports.

• Keep abreast of literature infield; attend meetings; help train junior colleagues; contribute to continuous improvement within the group.

• Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner.

• Maintain proper records according to all SOP's and policies.

• Performs analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, Gas, Water and manufacturing environmental sampling and testing according to the effective protocols.

• Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media.

• Maintains cultures according to ATCC and departmental Standard Operating Procedures.

• Performs identification of microorganisms using techniques such as API, Gram Stain, etc.

• Prepares reagents, standards, medias, etc. needed for analysis.

• Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks.

• Verifies co-workers’ calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data.

• Must be capable of writing and or revising Standard Operating Procedures and Test methods.

• Helps develop new analytical methods or modifies current methods.

• Able to participate in method transfers and assist with developing transfer protocols.

• On an as needed basis, maintains proper documentation of Laboratory equipment. Included; setting new equipment for use (IQ, OQ, PQ), training and routine maintenance (Preventative maintenance scheduling and calibrations), and repairs.

• May assist in providing guidance/training to new and existing personnel.

• Work on special projects as needed.

• Helps maintain and store supplies inventory.

• Disposes of hazardous waste according to environmental regulations and company/departmental procedures.

• Files and maintains laboratory records.

• Helps maintain inventory of glassware, chemicals and materials needed for chemical analysis.

• Required to calibrate, maintain and clean laboratory instruments and equipment.

• Required to read and execute departmental methods and SOPs.

Requirements
Education/Experience:

• Requires BS with college course work in related sciences.

• At least (5) years experience working in an analytical laboratory.

• At least 3 years experience with working knowledge of calibration, maintaining and clean laboratory instruments and equipment.

Required Must Have Skills/Experience:

• Must be able to provide training to new or existing personnel.

• Experience working with a LIMS database.

Excellent writing skills to be capable of writing and/or revising Standard Operating Procedures and Test methods.

• Fosters communication with group members and the supervisor.

• Handling and disposing of hazardous waste according to environmental regulations and company/departmental procedures.

Job Type: Contract

Pay: $39,193.00 - $119,525.00 per year

Physical Setting:

• Office

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: One location