The Job Auction Country

Share On

This listing has Ended
Go to My Listings


resume-library  |  United States  |  

United StatesUnited States (US)
Science/Biology & Biotech
Work Type:
Work Time:
Full Time



This position is focused on Microbiological assays. Experience in bioburden, the colony count method is preferred. The microbiologist will be responsible for ensuring routine testing is scheduled, completed, and reviewed within the required time frame. They will be available for troubleshooting. Other responsibilities would include Standard Operating Procedure (SOP) revisions, qualification/validation support, as well as representing Quality Control (QC) Microbiology in meetings and during internal and regulatory audits. Analysts may be required to perform testing as needed for supporting lab functions.ROLE RESPONSIBILITIES

* Performs tasks associated with maintaining current Good Manufacturing Practices (cGMP) compliant Quality Control and Stability laboratories.

* Performs testing as needed to support lab functions.

* Analyzes and interprets results, makes decisions regarding accuracy, completeness, and compliance; performs data trending.

* Responsible for appropriate creation, review, approval, and final authorization of GMP documentation (test results and records, validation protocols/reports, adherence to regulatory agency requirements, ICH guidelines, Company standards, policies, and values.

* Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.)

* Responsible for contributing to and/or handling laboratory investigations for events and OOS results including review.

* Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.

* Serve on cross-functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or networks.

* May initiate, lead a working group, and/or manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.


* BS/BA Degree in Science/related field with 6+ months of manufacturing, quality, or engineering experience in the biotech or pharmaceutical industry required; OR

* 2 Years of Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations

* Demonstrated experience in manufacturing, quality, or engineering experience in the biotech or pharmaceutical industry

* Understanding of aseptic laboratory techniques and quality systems

* Excellent effective written and verbal communication and interpersonal skills


* Experience in bioburden preferred

* cGMP Laboratory experience preferred

* Knowledge of and experience with the following is preferred:

* US, EU, and ROW cGMP; pharmacopeias; ICH guidelines

* Computer systems including Laboratory Information Management System (LIMS), Global Quality Tracking System (TrackWiseTM application); Microsoft Office applications specifically Word, Excel, and PowerPoint


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. Were 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.