What are the responsibilities and job description for the NOW HIRING: QC Analyst II position at Actalent?
Description:
Position Overview: The Quality Control Analyst – Microbiology EM/Utility is responsible for day-to-day operations related to Environmental and Utility Monitoring. Responsibilities include but are not limited to: • Perform routine activities for environmental monitoring in the manufacturing processing areas including viable, non-viable, surface, and personnel sampling. • Samples purified water systems at point of use for analysis of Bioburden, TOC, Conductivity, and Endotoxin. • Perform routine monitoring of other facility utilities including compressed air/ gas sampling. • Operate appropriate monitoring sampling and testing equipment. • Assists in the writing, reviewing, and editing of standard operating procedures • Compile and enter data into computer database to be used for reporting and trending purposes. • To ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures. • Individual must be able to maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development • Identify and troubleshoot equipment and software problems. Experience in troubleshooting LC systems when equipment malfunctions occur. • Participate in the investigation of non-conformances in compliance with quality procedures, policies, and regulations. • Individual must be quick to identify and resolve gaps that are identified during day-to-day operations. • Individual will assist in maintaining accurate lab inventories and will be responsible for ordering supplies as needed in the lab.
Skills:
GMP, QC, Quality Control, Micro Biology, Environmental Monitoring, Bioburden, TOC, Conductivity, Endotoxin, LIMS
Top Skills Details:
GMP,QC,Quality Control,Micro Biology,Environmental Monitoring,Bioburden,TOC,Conductivity,Endotoxin
Additional Skills & Qualifications:
Minimum requirements: • Bachelor’s degree in a scientific discipline, or equivalent years of relevant industry experience. • Minimum 5 years of experience in a Quality Control cGMP laboratory, preferably related to pharmaceutical industry operations • GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required • Effective communications skills and be knowledgeable in computer systems • Good troubleshooting skills for equipment and software • Ability to work independently (minimum supervision) • Ability to effectively collaborate with others • Excellent written and verbal communication skills • Excellent multi-tasking and organizational skills • Completes work in a timely manner • Understanding and ability to perform aseptic and relevant microbiological methods. • Ability to lift up to 20lbs • Frequent standing/walking to work in lab environments for extended periods • Prior experience working in a classified clean room is desired • Aseptic technique and the ability to gown into a sterile environment • Experience with LabVantage or other LIMS platforms a plus but not required
Experience Level:
Intermediate Level
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.
Salary : $63,000 - $77,000
