Demo

Quality Manager

Contemporary Staffing Inc
Albany, OH Full Time
POSTED ON 2/4/2025
AVAILABLE BEFORE 5/4/2025

Contemporary Staffing Solutions (CSS) is seeking a Quality Manager to join our client in Albany, OH! This permanent opportunity offers $120,000-$125,000 annually! The Quality Manager is responsible for overseeing quality assurance and quality control operations within a manufacturing environment. This role ensures all processes and activities comply with regulatory requirements and company standards, while leading a dedicated team, managing quality systems, and supporting regulatory inspections.

Key Responsibilities :

  • Manage all quality assurance and quality control activities, ensuring compliance with cGMP, USP standards, and regulatory requirements.
  • Review and approve controlled documents, including SOPs, batch records, specifications, deviation reports, and OOS investigations.
  • Approve change controls with proper justification, impact assessment, and implementation.
  • Oversee validation documentation to ensure product specifications are met.
  • Lead regulatory inspections and audits by federal and state agencies.
  • Manage vendor qualification and compliance in the vendor management program.
  • Communicate effectively with external laboratories regarding product testing.
  • Oversee quality checks for incoming materials and manage sample retention programs.
  • Lead and develop the quality team, ensuring efficient resource allocation.
  • Provide metrics and trend reports to senior leadership, identifying opportunities for improvement.
  • Stay updated on regulatory changes and implement necessary updates to maintain compliance.
  • Collaborate on projects related to inspections, quality agreements, audits, and validation activities.
  • Oversee sterility assurance programs and enhance quality systems.

Qualifications :

  • Bachelor's degree in a scientific or technical discipline.
  • 10 years of experience in biotech, pharmaceutical, or medical device industries.
  • 7 years in progressively responsible quality management roles.
  • Strong leadership experience managing quality teams.
  • In-depth knowledge of quality management systems (21 CFR Part 11).
  • Experience with FDA regulatory audits and agency interfacing.
  • Expertise in batch record review, batch disposition determination, and sterility assurance.
  • Excellent written, verbal, and interpersonal communication skills.
  • Proven ability to excel in a dynamic, fast-paced environment with shifting priorities.
  • Contemporary Staffing Solutions (CSS) has been a leading provider of contract, temporary, temporary-hire & direct hire solutions. We began as a staffing agency and evolved to a national provider of workforce management solutions with a niche recruitment focus in Accounting & Finance, Call Center & Office, Human Resources, Sales & Marketing, & Information Technology. To learn more about CSS, visit our website : www.ContemporaryStaffing.com.

    Salary : $120,000 - $125,000

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