Microbial Quality Control Specialist
2 weeks ago
Position Title: Microbial Quality Control Specialist
Contract Duration: 12 Months (Potential for Extension)
Location: Not Specified
Overview:
The Microbial Quality Control Specialist is responsible for executing and coordinating both routine and specialized testing within the Quality Control Microbiology department for bulk drug substances and pharmaceutical products in a multi-product environment.
Key Responsibilities:
- Independently perform essential operations such as bioburden testing, endotoxin assays, and growth promotion evaluations with appropriate training.
- Support internal operations by managing consumables, updating standard operating procedure (SOP) documentation, disposing of expired materials, and identifying/reporting any process or equipment irregularities.
- Deliver precise analytical results within established timelines, ensuring accuracy and quality in documentation in accordance with current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
- Comply with regulatory standards and cGMP guidelines, promptly reporting any abnormalities or deviations.
- Uphold safety protocols, recognizing unsafe practices and escalating concerns as necessary. Maintain work areas in accordance with predefined organizational standards.
- Ensure personal training remains compliant and assist in training fellow technicians and associates upon achieving trainer qualifications.
Qualifications:
Experience: 3-5 years of relevant industry experience, with a strong preference for candidates with Good Manufacturing Practice (GMP) experience.
Skills: Strong interpersonal and communication abilities (both written and verbal), a customer-centric approach, and the capability to collaborate effectively across various departments and organizational levels.
Attributes: Ability to work autonomously as well as collaboratively to achieve departmental and organizational objectives; strong attention to detail and focus on execution quality.
Education:
A Bachelor's degree in Biology or a related Life Sciences field is required.
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