Administrative Assistant; Quality Control

About the Role

The Administrative Assistant supports the QC Manager in one of the assigned QC laboratories (Raw Material, Finished Product, Microbiology, ICP, Technical Support) with tasks including maintenance of laboratory documentation, initiation of laboratory change controls, and coordination between internal departments.

Responsibilities

• Preparation and review of the certificate of analysis (CofA) for all tested materials, including review of testing results and manufacturing batch records.
• Communicate and provide information to other departments as requested.
• Coordinate with Regulatory Affairs to maintain and update specifications based on regulatory requirements and changes.
• Manage and support the laboratory by initiating change controls, drafting revisions to QC documentation (specifications, test methods, SOPs), 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 laboratory supplies and reagents by working with the laboratory and purchasing groups.
• Interact with outside contract laboratories for sample testing.
• Assist with and coordinate distribution of documents, procedures, instructions, and training.
• May assist in performing basic related tests as needed.
• Other responsibilities as assigned by Management.

Requirements

• Associate’s degree preferred; equivalent work experience acceptable.
• 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.
• Effective communication skills.

Physical Demands

• Required to sit and stand for long periods.
• Frequently reaching with arms/hands up to 2 feet.
• Good hand-eye coordination.
• Occasionally required to walk and kneel.
• Must lift and/or move up to 50 pounds.
• Must use close vision, distance vision, peripheral vision, color vision, and adjust focus.
• Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, and climb stairs.

Work Environment

• Work in laboratory and production facilities near heavy machinery and pharmaceutical powders.
• Potential to move between production sites/areas.
• Work hours/schedule subject to change based on business needs.
• Required to be present in the laboratory for daily testing and collaboration.
• Responsible for compliance with safety policies and regulations.

Personal Protective Equipment

• Gowning as required by GMPs and/or SOPs.

Pay

$21 per hour