Scientist Jobs in Concord, NC

Title : Sterility Assurance Scientist

Location : Concord, NC

Duration : 6 Month Contract (potential of extension)

Responsibilities :

The Sterility Assurance Scientist is a technical role that assists in development and implementation of the site’s

sterility assurance programs and provides technical guidance and expertise in environmental monitoring,

contamination control, aseptic process simulations, gowning / aseptic techniques, and cleaning / sanitization

strategies, including disinfectant efficacy. The principal role is a position that develops and implements a

technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The

principal role is also expected to serve as a mentor within the TSMS team and engage in upstream and external

to site activities related to sterility assurance contamination control strategies are established.

Key Objectives / Deliverables

• (Associate / Senior) Ensure and provide oversight and technical guidance for sterility assurance programs

at the manufacturing floor level.

assurance programs including but not limited to :

contamination control strategies are established.

ensure effective contamination control strategies are established.

contamination control strategy and cleaning and sanitization program / strategy, and disinfectant efficacy

strategies.

gowning and aseptic technique strategy / program.

microbiological enumeration techniques, and microorganism isolation and identification.

Aseptic Process Simulation (APS) program :

environmental isolated cultures.

Quality Standards are met for each manufacturing line / process.

with respect to potential introduction of microbial, endotoxin, and particulate contamination.

for continuous improvements.

programs.

assurance programs.

objectives.

Basic Qualifications :

Chemical Engineering, or other related scientific discipline.

parenteral drug products within operations, microbiology, environmental monitoring, sterility assurance,

validation, technical services, and / or quality assurance associated cGMP pharmaceutical manufacturing.

related dept).

related dept).

Additional Skills / Preferences :

and other departments.

warehouse, or laboratory areas.

Additional Information :

role as the development facility and processes progress. Must be flexible in providing support to

accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hours and / or

off-hour work may be required.

programs.

This job description is intended to provide a general overview of the job requirements at the time it was

prepared.

The job requirements of any position may change over time and may include additional responsibilities not

specifically described in the job description. For GMP purposes, the job description should be updated for

significant changes. As always, you should consult with your supervisor regarding your actual job

responsibilities and any related duties that may be required for the position.