Manufacturing Compliance Senior Specialist

Role Details

Title: Manufacturing Compliance Senior Specialist

Location: Devens, MA

Start date: ASAP

Our client is looking for the following:

Responsibilities:

• Conducts and manages resolution of deviations, root cause investigations, impact assessments and CAPAs as a Lead Investigator

• Liaises with many different groups/organizations as a Lead Investigator

• Proactively identifies and facilitates resolution of obstacles to timely completion.

• Proactively manages progression of investigation and CAPA to timely closure.

• Leads and participates in cross-functional investigation teams.

• Presents investigation findings to key stakeholders and site management.

• Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste

  With the following credentials:

  Requirements:

• Required BS in chemical/biochemical engineering, biological sciences, or a related discipline with 2-4 years relevant experience

• Prior experience in leading cGMP investigations utilizing formal Root Cause Analysis tools preferred.

• Demonstrated basic project management skills(organization, collaboration, multi-tasking and communication),attention to detail, and the ability to perform well in a team-based environment are required

• Excellent verbal & written communications skills, including ability to present information clearly and concisely.

• Excellent interpersonal and collaboration skills necessary to interface with and influence all levels of the organization.

• Prior experience with SOPs, cGMPs and the know how to work within a regulatory environment

• Prior experience in/Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred

  System One offers eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

System One provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.