Driving Advancements in Biopharmaceutical Manufacturing

PAK BioSolutions Seeking Quality Manager

14 Dec 2023

Job Description:

PAK BioSolutions is hiring a Quality Manager to oversee the company’s quality systems. This role will report to the company’s CEO and will ensure that employees comply with the quality procedures. This includes reviewing batch records, approving change controls, and maintaining employee training records. The individual will ensure that the company’s policies are appropriate to maintain ISO9001 certification and meet customer expectations. They will assist with customer questions and audits. The ideal candidate will have at least eight years of experience in the biopharmaceutical industry and a working knowledge of the typical biopharmaceutical quality systems and policies.

Responsibilities

  • Develop and implement quality management systems and processes to ensure compliance with industry standards and regulations.
  • Conduct quality audits to identify areas for improvement and implement corrective actions.
  • Oversee quality control processes, including inspection and testing of materials and finished products.
  • Collaborate with cross-functional teams to develop and implement quality initiatives.
  • Train employees on quality procedures and ensure adherence to quality standards.
  • Monitor and evaluate the effectiveness of quality systems through regular reporting and metrics analysis.

Requirements

  • Minimum of 8 years of experience in quality assurance or quality management in the biopharmaceutical industry.
  • Familiarity with CGMP (Current Good Manufacturing Practices) guidelines.
  • Experience conducting quality inspections and implementing quality control measures.
  • Knowledge of FDA regulations related to manufacturing and quality control.
  • Ability to analyze data and identify trends for process improvement.
  • Excellent communication skills, both written and verbal.
  • Bachelor’s degree

Benefits

  • 401(k) with company match
  • Health insurance
  • Dental & Vision insurance
  • Paid time off
  • Federal holidays
  • Flexible working hours
  • Lunch provided on Tuesdays
  • Telework (work from home) available on Fridays

Schedule

  • Full-Time
  • Monday to Friday

Company Description

PAK BioSolutions is an early-stage technology company that designs novel equipment for biopharmaceutical manufacturing facilities. The company’s first product offering is the Pilot PAK, an automated system for end-to-end continuous purification. PAK BioSolutions is the first and only company to offer a system of its kind. The company also provides patented single-use flow kits for use in the Pilot PAK system. Combined, these technologies provide over 4X productivity improvement and 50% capital reduction to customers. PAK BioSolutions is conveniently located near Tysons Corner, Virginia.

This is your chance to join a rapidly growing company with excellent corporate benefits and opportunities for professional development, internal promotions, and employee bonuses. We offer a clean, modern office with a friendly, respectful, and collaborative team. Low turnover rate, no more than 40 hours/week, windows with natural light, and dedication to employee health.

PAK BioSolutions is an EEO employer and is handicap accessible.

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