Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. In the Sellersville, PA Plant, the QC Analyst (Chemist) will coordinate & perform analytical testing based upon skill and experience.
B.S. in chemistry or related science
Excellent computer skills including MS Office
Proficiency in HPLC/GC and the Final Release Audit
Perform calibrations and troubleshoot instrumentation as needed
Strong knowledge of FDA, USP, ICH, cGMP, and cGLP requirements in a pharmaceutical quality control laboratory
Excellent organizational skills and attention to detail, self-driven, and motivated
Excellent at multitasking, handling multiple projects at one time, and changing priorities based on business needs
Excellent interpersonal, oral, and written communication skills
Write Laboratory Investigation Reports (LIRs)
Able to work effectively independently and as part of a team
Experience training other analysts in laboratory techniques such as Wet Chemistry, HPLC, or other instrumentation
Strong technical writing skills
Description of Responsibility
Read and interpret analytical methodology, documentation and the USP.
Calibration/validation of analytical instrumentation.
Perform analytical testing of finished dosage pharmaceutical products and/or raw materials following analytical methodology
Maintain accurate, detailed records of work performed using LIMS or other data collection media.
Proficient at HPLC/GC analysis, troubleshooting and calibration.
Work with the LIMS software program documenting and creating laboratory data.
Proficient at the Final Release Audit of laboratory paperwork and in LIMS. Write, update, and evaluate new test methods, SOPs, LPMs, using USP, NF, method validation.
Write laboratory reports, memos, and/or other interdepartmental correspondence.
Assist in ensuring testing is in adherence to schedules through team oriented process.
Train other analysts.
Represent department on project and cross-functional teams and committees.