Administrative Assistant; Quality Control

Description

Position Summary:

The Administrative Assistant is responsible for assisting the QC Manager in one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, ICP, Technical Support) with any tasks including, but not limited to, maintenance of laboratory documentation, initiation of laboratory change controls, and direct communication and coordination between all internal departments.

Responsibilities: Responsibilities include, but are not limited to: 

• Preparation and review of the certificate of analysis (CofA) for all materials tested. Includes review of testing results reported and manufacturing batch records, as required.
• Communicate and provide information to other departments, as requested.
• Coordinate with the Regulatory Affairs group to maintain and update specifications as required based on regulation requirements and changes. 
• Manage and support the laboratory by initiating change controls, drafting revisions to QC documentation (specifications, test methods, SOPs, etc.), and completing action items within the electronic quality management system. 
• Maintain current and retired QC documents.
• Maintain spreadsheets for tracking departmental metrics, laboratory performance, and material release.
• Monitor and maintain proper inventory levels of all laboratory supplies and reagents by working with the laboratory and purchasing groups.
• Interact with all outside contract laboratories used for testing of samples.
• Assist with and coordinate distribution of documents, procedures, instructions, and training.
• May be required to assist in performing basic related tests, as needed.
• Other responsibilities as assigned by Management.

Requirements

Education and Experience:

• Associate’s degree preferred; equivalent years’ work experience is acceptable.

Skills, Knowledge, and Abilities:

• Proficiency in Microsoft Word, Excel, graphs/charts and databases.
• Ability to multitask and meet tight deadlines.
• Excellent organizational and follow-up skills with attention to detail.
• Ability to communicate effectively.

Physical Demands:

• Required to sit and stand for long periods of time. 
• Frequently reaching with arms/hands up to 2 feet. 
• Good hand eye coordination. 
• Occasionally required to walk and kneel.
• Must be able to lift and/or move up to 50 pounds.
• Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus. 
• Required to reach with arms and use hands and fingers to handle or feel objects, tools and computer controls.
• Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs.

Work Environment:

• Work environment in laboratory and production operations facilities include close proximity to heavy machinery and pharmaceutical powders.
• Potential to move between production operations sites/areas to complete job functions. 
• Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
• Required to be present in the laboratory to perform daily testing and collaborate with department director, manager, and peers.
• Responsible for compliance with all rules and regulations pertaining to safety policies with the proper attitude toward safety and health, helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel.

Supervisory Responsibilities:

• None

Personal Protective Equipment or Attire Required for Position: 

• Gowning as required by GMPs and/or SOPs.

Pay Range:

$21 per hour