What are the responsibilities and job description for the QA Specialist II / III position at Pace Analytical Services, LLC?
Job Title:Quality Assurance Specialist II / III
Job Type:Full-Time
Job Description:We are seeking a meticulous and experienced Quality Assurance Specialist to join our Quality Assurance team. The ideal candidate will have experience in a sterile fill finish manufacturing environment and a strong understanding of quality assurance principles. This role is vital to ensuring our products meet the highest standards of quality and compliance.
The exact job title will be determined based on the candidate's experience and expertise.
Key Responsibilities:
- Develop, implement, and maintain quality assurance programs and procedures.
- Conduct audits and inspections of manufacturing processes and facilities to ensure compliance with GMP, SOPs, and regulatory requirements.
- Review and approve batch records, deviations, and change controls.
- Investigate and resolve quality issues and non-conformances.
- Collaborate with cross-functional teams to support continuous improvement initiatives.
- Provide training and guidance to staff on quality assurance practices and regulatory requirements.
- Prepare and present quality reports and metrics to management.
- Stay current with industry trends and regulatory updates.
Qualifications:
- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or a related field.
- Minimum of 3-5 years of experience in a quality assurance role within a sterile fill finish manufacturing environment.
- Strong knowledge of GMP, FDA regulations, and other relevant quality standards.
- Familiarity with EU regulations .
- Excellent attention to detail and analytical skills.
- Ability to work independently and as part of a team.
- Strong communication and documentation skills.
- Proficiency in quality management systems and software.
Pace Life Sciences
Pace makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace provides professional services to support their operations.
Pace Analytical is an equal opportunity employer.
