- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- We will continue to focus on advancing therapies that are the first or best of their kind.
- By providing a foundation for all operations company wide,our company’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases.
- Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
- We are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
- The Quality Assurance Associate reports to the Quality Assurance Manager, and is responsible for supporting site quality systems, site start-up, inspection readiness and assisting with the batch release process for drug substance.
- Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives
- Support the Technology Transfer of a new product into the site including raw material and supplier qualification.
- Support quality systems on site
- Review and approve standard operating procedures (SOPs) and master batch records.
- Review and approve deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
- Assist with internal audits to ensure compliance with cGMPs and other regulatory requirements.
- Assist with regulatory inspections.
- Support the following activities, as appropriate:
- Document Control
- New or updates to relevant quality agreements
- Validation activities
- Annual Product Reviews
- Complaints, recalls and/or notification of events to regulatory agencies
- Other duties as assigned
• Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- Minimum 5 years’ relevant experience in a cGMP regulated manufacturing and packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- Strong ability to communicate, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
- This position will require interaction with multiple levels in Quality Assurance, Quality Control, Contract manufacturers, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources.
- This description is not intended to be all-inclusive or a limitation of the duties of the position.
- It is intended to describe the general nature of the job that may include other duties as assumed or assigned.