QA & Compliance Leader, FDA-Ready & cGMP

STASKA PHARMACEUTICALS; Indiana (PA); On-site; USD 110,000 - 150,000; Full time

Job summary

STASKA PHARMACEUTICALS is seeking a Quality Assurance Manager to lead the development, implementation, and maintenance of QA systems in a cGMP environment.

The role requires oversight of audits, CAPA programs, and validation activities to ensure sterile product manufacturing compliance. A Bachelor’s in Chemistry or Pharmaceutical Sciences and 5+ years in QA/related roles are essential.

Qualifications

• Bachelor’s degree in Chemistry or Pharmaceutical Sciences is required.
• Five years’ work experience as Quality Control Manager or related occupation is required.
• Experience developing and maintaining QA systems and ensuring cGMP compliance is expected.

Responsibilities

• Plan, manage and coordinate the development, implementation and maintenance of quality assurance systems.
• Ensure compliance of company operations to quality principles and cGMP requirements.
• Develop and implement corrective and preventive action plans to prevent or correct deficiencies.
• Develop and implement quality systems including drafting/implementing SOPs and managing training of scientific & production teams on laboratory, QC and analytical procedures.
• Act as subject matter lead in FDA inspections, audits and other Quality Assurance tasks.
• Review and approve qualification and validation protocols and plans for clean-rooms, systems, and process activities associated with the manufacturing of sterile products in aseptic environments.
• Direct the development and implementation of validation test procedures to ensure products meet validation requirements.

Skills

Quality Assurance

cGMP compliance

Auditing

SOP drafting

Training teams

FDA inspections

Education

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Job description

STASKA PHARMACEUTICALS is seeking a Quality Assurance Manager to lead the development, implementation, and maintenance of QA systems in a cGMP environment.

The role requires oversight of audits, CAPA programs, and validation activities to ensure sterile product manufacturing compliance. A Bachelor’s in Chemistry or Pharmaceutical Sciences and 5+ years in QA/related roles are essential.