QC Microbiologist I/II

Employer
Actalent
Location
Franklin County, Massachusetts, US
Salary
Competitive
Posted
Jul 10, 2021
Closes
Jul 23, 2021
Ref
2307875551
Discipline
Other
Employment Type
Full time
Salary Type
Salary
IIf interested, please send your resume to marcmill@actalentservices.com
Description:
The Quality Control Analyst I/II in Microbiology performs microbiological analysis of in-process, release and stability samples to support the biomanufacturing facility. In addition, the QC Analyst may cross-train with the QC Analytical team in order to support in-process analytical testing.
Duties and Responsibilities
. In accordance with test method SOP's, perform microbiological analyses including Bioburden, Endotoxin, TOC, Conductivity, Nitrates, Appearance testing, Media performance, Growth promotion and Microbial Identifications.
. Perform analytical tests as needed such as pH, basic spectrophotometric methods such as A280nm and A550nm, and potency testing.
. Perform environmental monitoring of cleanrooms and water system sampling.
. Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, Eu. Ph.,GLP, GDP, QSR, and CGMP regulations.
. Investigate, assess, and troubleshoot assay and/or equipment problems.
. Notify QC Manager immediately when a deviation, an aberrant result, or an OOT/OOS result is discovered. Initiate and participate in authoring investigation reports.
. Support investigations of deviations and prepare exception documents, utilizing problem solving tools as needed.
. Participate in method qualifications, validations, and transfers.
. Maintain sample tracking and integrity at all times until analyses are reviewed.
. Prepare and complete change control requests using electronic systems, e.g., Trackwise.
. Actively contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
. Support Lean principles such as 5S throughout daily work activities.
. Ensure personal training requirements are met and that training records are current.
. Ensure analytical equipment is calibrated and well maintained at all times.
. Perform general lab maintenance. Order supplies as needed, store materials as indicated and discard expired materials as per manufacturer or test method recommendations.
Skills:
Endotoxin, Bioburden, Quality Control, Microbiology, Environmental Monitoring, Aseptic Technique, GMP, TOC, conductivity, Microbiology
Additional Skills & Qualifications:
. Bachelor's degree in a scientific discipline.
. Minimum 3- 5 years' experience in biopharmaceutical Quality Control in a GMP environment with specific experience in microbiological testing and sampling.
. Ability to participate in holiday and weekend coverage is required.
. Demonstrated experience using relevant QC procedures, specifications, regulations and standards.
. Knowledge and control of lab testing equipment including determining when and what kind of maintenance is needed.
. Demonstrated competence in use of computer software, including relevant applications such as Microsoft Office and LIMS.
. Knowledge of CGMPs regulations including GMP practices for method transfer, qualification and validation.
. Demonstrated understanding of quality systems including change control, deviations and CAPAs.
. Knowledge of aseptic technique and impact of product and facility contamination. This includes the performance of microbial identifications and relevant investigations to understand the source of contamination and means to prevent or minimize further occurrence.
. Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
. Strong written and verbal language skills to effectively read and write SOP's, related lab reports, and communicate technical information to audiences with varying levels of technical knowledge.
. Proficient in Microsoft Office - Outlook, Word, Excel, Powerpoint
Shift:
Standard scheudle M-F
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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