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location: Cambridge, Massachusetts
job type: Contract
salary: $32.92 - 38.73 per hour
work hours: 9 to 5
The Associate, Quality Systems & Operations will assist with the maintenance of compliance programs and providing critical support for the management of clinical programs and knowledge management systems in the company's GCP GVP space. This role will be responsible for liaising with multiple internal expertise areas to ensure the company continues to fulfill its high quality standards.
- Assist in the maintenance of GCP and GVP quality systems, particularly those that interface with Deviations, CAPAs, and Audits.
- Facilitate timely closure of Quality records with proactive communication involving record owners and quality personnel.
- Maintain and assist in the development and reporting of quality metrics, particularly those pertaining to Deviations, CAPAs, Effectiveness Checks, training compliance, and documentation.
- Promote compliance within the company and represent QA, as required.
- Build, develop, and maintain good working relationships with internal and expertise areas.
- Timely data management of internal and external audit records, including timely communication with vendors to support closure or extension audit content.
- Maintain and update content related to our approved vendors.
- Work with internal GCP and GVP customers and develop and execute strategic audit activities under the guidance of Quality management.
- Provide support for Investigator Site audits
- Participate in company preparations for regulatory inspections.
- Facilitate knowledge management initiatives ensuring the archival of outputs from site, sponsor, or CRO inspections, audits, and nonconformances.
- Assist in the compilation of the CSR with respect to Quality Events.
- Engage in initiatives across the organization to assist in establishing a Quality mindset.
- Support onboarding activities across the organization
- Participate in cross-functional quality system initiatives representing GCP/GVP QA
- Other assignments as directed by the Quality Assurance management team.
- Educated to degree level, preferably life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification.
- Up to 2 years of experience in a biotech or pharmaceutical environment. A background in Quality is preferred, but not required.
- Experience or familiarity with deviations and metrics
- Excellent interpersonal, verbal, and written communication skills, including experience with meeting presentations.
- Experience with Microsoft based applications and a demonstrated ability to learn new computer systems.
- Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork.
- Ability to work consistently, flexibly, and adjust to changing priorities in a fast-paced environment.
- Excellent attention to detail and time management skills in the context of managing multiple priorities with aggressive timelines.
- Ability to identify quality issues/discrepancies, and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner.
- Demonstrate good judgment and decision-making experience.
- Work professionally with highly confidential information.
- Work independently and within a team.
skills: SOP, Quality Assurance, CAPA, Chemistry, GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.