Quality Control Associate Scientist II
|Monroe, North Carolina - United States
$45,000.00 - $65,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Quality Control Associate Scientist II to join our growing team. The QC Associate Scientist II position supports the Quality Control group to maintain process optimization and manufacturing activities. The QC Associate Scientist II is responsible for a highly motivated member of the Quality Control (QC) Lab at the manufacturing facility, reporting to the QC Manager. Primary responsibilities for this position will be: perform QC analysis in compliance to cGMP in line with standards prescribed by USFDA. Maintain compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA. Perform IOQ/Calibration for instruments in QC lab with guidance of CQA. Execute and complete procedures and systems for RM, PM, FD and in process testing in QC lab. Provide information, data for evaluation and execution of stability study as per Quality and regulatory requirement. Timely complete testing and ensure compliance during analytical TT and AMV performed in QC lab. Able to be a qualified trainer for QC related systems and SOP’s and responsible that personnel are appropriately trained.
Responsibilities include but are not limited to:
- Perform day to day activities for the chemical laboratory which shall include sampling of raw materials and packaging materials (as applicable).
- Perform day to day activities for the chemical laboratory which shall include testing of in-process, raw material, packaging material, finished product, and swab samples (as applicable).
- Ensuring compliance to systems and procedures in finished product section.
- Communicate with Supervisor and/or report any preparations or data that may result in an incidence and out-of-specification (OOS).
- Ensure that the QC Laboratory is in a ready state of compliance for internal and external audits.
- Maintain accurate and complete test records.
- Help maintain inventory by reporting needed supplies.
- Packaging and sending samples to contract laboratories.
- Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
- Maintain current knowledge of regulatory and industry standards, trends and advancements.
- Execute technology transfer of analytical methods for new products. Execute cleaning validation of new products.
- Assist in the monitoring of changes in the monographs Pharmacopoeia requirements, Regulatory agencies recommendations and implement the same in QC Lab.
- Apply CAPA for Lab failures in OOS.
- Bachelors degree in Chemistry, or closely related scientific discipline. Degree in Chemistry is highly preferred.
- 0- 5 years in the field of Pharmaceutical (manufacturing facility).
Background in the functional areas of Quality Control in stability, finished product and raw material testing.
- Basic understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
- Knowledge in general laboratory equipment including but not limited to: HPLC, GC, UV-Vis and FTIR.
Knowledge & Skills:
- Ability to follow written instructions and to perform tasks with direct or minimal supervision.
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Excellent verbal and written communication. Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc. Knowledge of LIMS (Laboratory Information Management System) is a plus.
- Knowledge of cGMP, Regulatory guidelines, Compendial testing (USP), Internal auditing.
- Skills in coordination of calibration and preventative maintenance services, including but not limited to: setting up vendor contracts, processing quotes, generating purchasing orders and handling vendor invoices.
- Technical writing skills to generate SOPs and serve as the Subject Matter Expert.
- Support the Management to organize and maintain the QC team and good communications skills, front runner and GMP trainer.
- Must have worked in Regulatory environment.
- Will be an added advantage if the individual has dealt with multiple audits personally.
University - Bachelor's Degree/3-4 Year Degree