Skills

Monitoring GCP

Job Specifications

1st, 2nd, and 3rd shifts available

Overview:

Performs a variety of tasks related to the processing of ingredients and/or pharmaceutical products. Operates general manufacturing equipment, such as autoclaves, and automated aseptic filling lines. Handles raw materials and intermediate or finished products.

Job Description

Assists in all direct manufacturing support functions such as Thaw, Blend, Fill, Stage, Prep, Environmental and Monitoring (EM) and equipment preparation.
Assists in indirect manufacturing support functions, such as cleaning and sanitization of the facility.
Performs standard operating procedures to meet current good manufacturing practices (GMP).
Accurately completes required documentation to comply with Federal regulations and assists with batch-record close-out.
Maintains product related records as required.
Author and revisor of SOPs and Batch records as needed.
Responsible for all aspects in the aseptic manufacturing of product to ensure product quality and patient safety.
Responsible for all manufacturing support functions such as preparation of equipment and manufacturing components to be used in support of/or manufacturing of the product.
Operates basic equipment (i.e. scale and/or balance, autoclave, pH meter, environmental monitoring equipment) as delineated in standard operating procedures.
Prepares and formulates specially cleaners and/or solutions, etc. needed for cleaning and/or to be used in the manufacturing processes and/or support areas were specified by standard operating procedures.
Carry out assignments in a timely, diligent and safe manner to comply with Regulatory agencies both domestic and international (i.e. CFR, EMEA).
Accurately complete documentation to comply with FDA and GCP/GLP/GMP regulations.

Skills and Experience

Essential

Able to physically lift and carry up to 40 lbs., without assistance, on an occasional basis and capable of working in various environmental environments.
Must be cleared to wear air filtering (face mask type) respirators and personal protective equipment.

Desirable

Auto-clave experience
Aseptic background

About the Company

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the c... Know more