Quality Floor Specialist (Nights)

Essential Functions

• Perform on-the-floor quality review of log books, cleaning records, batch records, and analytical data.
• Conducts complex quality floor inspections and process walkthroughs.
• Provide real-time quality guidance to Manufacturing personnel during active operations.
• Independently identify, document, and escalate observed quality or compliance concerns.
• Proactively identify emerging risks and require timely corrective actions prior to batch completion when possible.
• Performs line and area clearance in coordination with manufacturing personnel.
• Exercise quality authority to approve, restrict, or halt activities when quality or compliance risks are identified.
• Provide training in quality and compliance topics in areas of expertise.
• Ability to identify and implement quality improvement initiatives.
• Absorb and maintain accurate files and records.
• Serves as an effective member of the Quality team and may serve as a mentor to other employees in the area of expertise.

Key Competencies

• Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Ability to apply regulations and procedures to make real-time quality decisions.
• Demonstrated risk awareness in fast-paced manufacturing environment.
• Proven ability to act independently and exercise quality authority.
• Proficiency in SAP and electronic quality systems.
• Excellent written and oral communication skills for internal and client interactions.
• Good math skills.
• Ability to be trained and to mentor.
• Ability to interact well with employees at all levels.
• Proficiency with Microsoft Office products.

Education and Experience

• Bachelor's degree in chemistry, Biology, or related field with 3+ years GMP related experience, or
• Master's degree in related field with 1+ years related experience, or
• Equivalent educational and work experience.

Travel Requirement

• Up to 5% travel required.