QC Analyst lI - Chemistry

Quality & Compliance Horsham, Pennsylvania


Description

Job Summary - a concise overview of the job

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 III will have responsibility for coordinating the bioanalytical technology transfer from outside departments and to outside contractors.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

QC Chemistry Department.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

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.

60%

Documentation

§  Completes appropriate documentation to support testing procedures including data capture forms, equipment logbooks, and inventory forms.

10%

GMP Compliance

§  Applies knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) on a daily basis.

10%

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.

10%

Technical Transfer

§  Coordinates bioanalytical technology transfer from outside departments and to outside contractors.

5%

Other Tasks

§  Other duties as assigned by QC management.

5%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  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.

§  General experience in a development, quality, or manufacturing environment preferred.

Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  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.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  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.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  Lifting up to 40 lbs.

§  Able to stand for extended periods of time.

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify