QC Associate Job Description Template
Our company is looking for a QC Associate to join our team.
Responsibilities:
- May train less experienced analysts on basic and some more complex test methods;
- May write and revise SOPs for managerial review and approval;
- Performs routine testing and data review of stability and batch release samples in a cGMP compliant environment;
- Performs broad range of troubleshooting techniques and leads such within area of expertise;
- Adherence to all GMP requirements, effective interactions/communication with Quality management, personal development, and support of investigations;
- Performs testing, and all associated activities associated with this testing;
- Able to work effectively within the group;
- A fundamental understanding of the Quality Systems and able to apply it in their daily support functions;
- Performs broad range of instrument maintenance, reagent preparation, and lab support functions;
- Performs routine cell culture maintenance and cell based potency bioassays.
Requirements:
- Demonstrates problem solving and analytical thinking skills;
- Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices;
- High attention to detail with strong general laboratory and good organizational skills;
- Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints;
- Knowledge of science generally attained through studies resulting in a BS degree, preferably in Chemistry, Molecular Biology, or related discipline;
- Knowledge of lab software applications (e.g., LIMS, (LES/SmartLab)) preferred;
- Experience in analytical test methods such as UV/Vis, Osmolality, Moisture analysis and particulate identification is highly preferred;
- Understanding of basic biological science principles;
- Developing or demonstrated instrument/method troubleshooting and problem solving skills;
- 0-2 years of relevant experience (BS degree) 2+ years of relevant experience (A.S. degree);
- Effective organizational skills;
- Ability to multi-task and coordinate multiple activities in parallel;
- General knowledge of FDA/EMEA regulations and compliance;
- Experience in aseptic cell culture maintenance and bioassay is highly preferred;
- Occasional contact with other line management staff relating to specific project responsibilities may be expected.