Quality Control Associate
1 month ago
Job Description: Quality Control Associate
Overview:
The Quality Control (QC) Associate plays a critical role in supporting microbiology laboratory operations under general supervision. This position involves performing routine microbiological testing, data documentation, and compliance with safety and regulatory guidelines.
Key Responsibilities:
- Conduct routine microbiological laboratory procedures, including bioburden and microbial count testing, biological indicator testing, growth promotion testing, and media inspections.
- Analyze environmental monitoring samples and ensure compliance with standard operating procedures (SOPs).
- Document, compute, and enter data in Laboratory Information Management Systems (LIMS) or SmartLab (LMES) with accuracy.
- Maintain specialized laboratory equipment and ensure preventive maintenance is performed on schedule.
- Participate in investigations of out-of-specification results and support internal and external audits.
- Support lab organization and cleanliness, including archiving documentation and preliminary plate readings.
- Collaborate with team members to implement lab improvements and troubleshoot issues as they arise.
- Maintain adherence to safety guidelines, cGMPs, and other regulatory requirements.
Qualifications Basic:
- Bachelor’s degree in a relevant scientific discipline with one year of related experience; or an equivalent combination of education and experience.
- Associate degree with six years of relevant experience; or a high school diploma/GED with eight years of related experience.
Preferred:
- Experience with GxP practices in biopharmaceutical testing and familiarity with QC systems such as CDOCS (Veeva Vault), LIMS, and SmartLab.
- Knowledge of data integrity requirements in QC processes.
- Proficiency in Microsoft Office and excellent problem-solving capabilities.
Skills:
- Strong written and oral communication skills.
- Detail-oriented with the ability to manage multiple priorities and meet deadlines.
- Flexibility and adaptability to changing requirements.
- Understanding of regulatory compliance and safety guidelines.
Physical Requirements:
- Ability to perform tasks requiring personal protective equipment and to lift/carry objects up to 15 pounds.
- Frequent tasks include fine hand manipulation and desk-based computer work.
Working Conditions:
- On-site work schedule of Monday to Friday, with potential weekend and holiday shifts based on operational needs.
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