QC Analyst II - Chemistry

Mallinckrodt Pharmaceuticals•Horsham, PA

31d

About The Position

The QC Analyst II - Chemistry will provide bioanalytical expertise for the Quality Control (QC) department. Key areas of focus are development and implementation of the quality aspects of late stage or marketed product strategy. This role is involved with performing and assisting with OOS investigation and resolution. Additionally, the Analyst II will have responsibility for coordinating the bioanalytical technology transfer from outside departments and to outside contractors.

Requirements

B.S. in a Biological Science or related field with a minimum of 3-5 years' experience in pharmaceutical or biotechnology industry required OR
M.S. in a Biological Science or related field with a minimum of 1-3 years' experience in pharmaceutical or biotechnology industry.
Working knowledge in protein chemistry and standard analytical techniques used in the biopharmaceutical industry (e.g., HPLC, FT-IR, SDS-PAGE, UV-Vis, IEF, Capillary Electrophoresis, ELISA).
Working knowledge of cGMP practices, ICH requirements, stability, and validation required.
Understanding of basic statistical analysis and familiarity with the use of databases is desirable.
Strong verbal and communication skills required.
Proficient in common software applications.
Ability to handle multiple priorities in a fast paced environment.
Demonstrates excellent interpersonal skills and flexibility.
Advanced writing skills.
Proficient in running a great number of methods.
Apply acquired biopharmaceutical skills to projects and assignments.

Responsibilities

QC Testing/Safety
Testing responsibilities may include RP-HPLC, SEC, KF, FT-IR, SDS-PAGE, and UV-Vis.
Adheres to Company safety procedures and guidelines on a daily basis
Documentation
Adheres to Company safety procedures and guidelines on a daily basis.
GMP Compliance
Adheres to Company safety procedures and guidelines on a daily basis.
Technical Writing & Investigations
Assists with preparing new SOPs / test methods or revising of existing documentation.
Performs and assists with OOS investigations, deviation response, and resolution.
Writes Change Controls, Deviation Investigations (DI's), Laboratory Assessments (LA's), CAPA's, and OOS investigation.
Technical Transfer
Writes Change Controls, Deviation Investigations (DI's), Laboratory Assessments (LA's), CAPA's, and OOS investigation
Other Tasks
Writes Change Controls, Deviation Investigations (DI's), Laboratory Assessments (LA's), CAPA's, and OOS investigation.