A fast pace customer & patient centered environment for a QC Chemist

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. 

Qualifications

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.