What are the responsibilities and job description for the Quality Control Analyst position at Beacon Hill?
Description:
- Perform day to day activities for the chemical laboratory which shall include testing of in- process, RM, PM and FP samples, Swab sample and Tech Transfer (as applicable).
- Ensuring compliance to systems and procedures throughout product lifecycle.
- Communicate with Supervisor and/or report any preparations or data that may result in an Incidence & OOS.
- Ensure that the QC Laboratory is in a ready state of compliance for internal and external audits.
- 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.
- Complete and maintain certified investigator training requirements to ensure SIT representation for identified area(s).
- Performing the investigation of quality events assigned using root cause analysis tools defined by company procedures, maintain timelines for closure of investigations assigned and to identify and initiate CAPA’s.
- Participate in continuous improvement initiatives for investigations and associated investigation certification process.
- Work with CIT team as needed for Major and Critical Investigations to align with corporate guidelines.
Requirements:
- B.Sc. in Chemistry
- 1-3 years in the field of Pharmaceutical (manufacturing facility).
- Background in the functional areas of Quality Control in Stability, Finished Goods and some Raw Materials with a some experience in R&D.
- Extensive knowledge in general laboratory equipment including but not limited to: HPLC, UV-Vis and FTIR.
- Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquainted with QMS, well versed with Change control/deviations and market compliant management system.
- 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.
- Completed training on Six Sigma, certified Green belt professional.
