This is an onsite, full-time Quality Assurance Specialist II position supporting the Woburn, MA, and Salem, NH, sites Monday - Friday, from 8:30 a.m. - 5:00 p.m.
Job Description: We are seeking a meticulous and experienced Quality Assurance Specialist to join our Quality Assurance team. This position will be in Woburn, MA but will also support manufacturing activities at our Salem, NH site. The ideal candidate will have experience in early phase sterile fill finish manufacturing environment as well as experience in GLP support work as well as a strong understanding of quality assurance principles. This role is vital to ensuring our products and data meet the highest standards of quality and compliance.
Key Responsibilities:
- Develop, implement, and maintain quality assurance programs and procedures in both a GLP environment and an early phase manufacturing cGMP environment.
- Conduct audits and inspections of manufacturing processes and facilities to ensure compliance with GMP, SOPs, and regulatory requirements.
- Conduct Phase Audits for all GLP projects
- Review and approve batch records, deviations, and change controls.
- Review and assemble reports for GLP clients.
- 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.
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, GLP, 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.
PHYSICAL/MENTAL REQUIREMENTS:
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in a lab and office setting, use standard office and lab equipment and stamina to sit and stand for extended periods of time; exerting up to 40 pounds of force occasionally and/or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
WORKING ENVIRONMENT:
Work is performed in a lab, warehouse and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab and samples setting.
Qualifications
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.