Top Biopharma client of ours is looking to add a QC Microbiologist to their team!!
The Quality Control Analyst II in Microbiology performs microbiological analysis of in-process, release
and stability samples to support the manufacturing of Obizur, an FDA-approved treatment for Hemophilia
A produced in the company's Milford biomanufacturing facility. In addition, the QC Analyst may crosstrain
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.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
Aerotek is acting as an Employment Agency in relation to this vacancy.
Posting ID: 574222044Posted: 2020-09-18