Job Description

Microbiologist III – Lynchburg, VA

Kelly Science and Clinical is currently recruiting for a qualified, contract Microbiologist III in the Lynchburg, VA area for one of our clients. The position is slated to last until Aug 2025. This is a great opportunity for someone looking for contract work, in between jobs, or looking to work a bit longer in industry. The need to fill is immediate!

Summary:

This position provides support for various Quality System functions. The primary job function includes support for Quality Control, new product development, microbiological evaluation, and method validation, change control, validation, investigation, internal audit, and calibration. Support the development of various technical documents: technical and manufacturing requirements, SOPs, specifications, test plans, validation protocols, and summary reports.

Responsibilities:

• Ensure quality activities are completed in accordance with project timelines.
• Ensure the change control program is followed and completed in accordance with company procedures and GMPs.
• Perform as a backup to supervisor duties and responsibilities as needed.
• Support the microbiological lab to develop technical assessments, method suitability protocols and reports, and overall microbiological assessments per established procedures.
• Manage the Change Control program for changes to existing products, raw materials, packaging materials, processes, and equipment.
• Review change controls and provide impact assessments for quality assurance.
• Execute IQ/OQ/PQ, cleaning, process, and utility validation protocols.
• Prepare detailed and concise validation reports.
• Ensure training documentation is completed and filed correctly for the microbiology lab.
• Perform data review related to validation protocols.
• Complete complex and critical manufacturing, packaging, and Quality Control investigations; utilizing root cause analysis tools and technical writing skills to document findings, corrective, and preventive actions, and recommend disposition.
• Participate in the Internal Audit Program by serving as a lead auditor or audit team member.
• Manage the environmental monitoring program to ensure all locations are sampled on time and within acceptance criteria. Ensure reports are generated and accurate.
• Analyze microbiological results to ensure no issues or trends are observed in products, manufacturing, or systems throughout the facility.
• Review and approve calibration documents, maintenance work orders, and required documents.
• Support the release of completed finished products and raw materials.
• Create and execute protocols for investigations, new products, or monitoring purposes.
• Perform training for Quality personnel and other company personnel, as necessary.
• Support new product development processes by performing reviews and approval of technical documentation.
• Create, revise, and review standard operating procedures.

Qualifications/Education/Skills:

• A Minimum of a BS degree in a scientific discipline or the equivalent.
• A Minimum of 8 years of experience in a GMP environment and quality control laboratory
• Knowledge of antimicrobial effectiveness testing, test method suitability, and developing test methods highly desired.
• Experience in equipment, Critical Systems Qualification, and validation are preferred
• Knowledge of the cGMP regulations and aseptic technique is essential.
• Able to understand and apply company SOPs.
• Working knowledge of Microsoft Word, Access, and Excel.
• Good written and verbal communication skills.
• Knowledge of USP and ISO standards
• Able to work independently

Pay : $30/hr

Hours: M-F, 9AM – 5PMEST

For immediate consideration or more information, please contact me directly at Tierra.Barbour@kellyscientific.com or at 804-991-0745.

Job Tags

Similar Jobs