Job Description
AQC Analyst performs analytical chemistry testing to support in-process and bulk drug substance manufacture within a cGMP regulatory environment.
* Gathers data and documents test results.
* Reviews test results to ensure compliance with standards and reports any quality anomalies.
* Complies with all pertinent regulatory agency requirements.
* Participates in required training activities.
* Maintains laboratory supplies.
The ideal candidate will be required to work shifts which include days & nights.
A typical day might include:
* Gathering data and documenting test results.
* Reviewing test results to ensure compliance with standards; reports any quality anomalies.
* Complying with all pertinent regulatory agency requirements.
* Participating in required training activities.
* Maintaining laboratory supplies.
* Conducting testing on raw materials, in-process, product, stability, and/or research samples.
* Developing and revising control test procedures and SOPs.
* Completing test records and reviewing data.
* Verifying calibration of instruments/devices prior to use.
* Interacting with outside customers or functional peer groups.
* Owning the responsibility for maintaining specific projects.
* Developing new analytical methods and techniques.
* Assisting in validating methods.
* Participating in establishing the transfer of methodology from R&D.
This role requires strong problem-solving skills, attention to detail, excellent written and oral communication skills, and the ability to maintain accurate records.