Hybrid Compliance Specialist II bei Curia

Compliance Specialist II – Burlington, MA

Build your future at Curia, where our work has the power to save lives

The Site Quality Systems and Compliance Specialist II is responsible for all functions associated with customer and internal audits. This position is responsible for developing audit schedules, accompanying customer groups on audits, documenting the course of each audit, communicating results of audit findings, facilitating any follow-up corrective actions and responses, managing the process until closure is successfully completed. This position assures the processes to manufacture and distribute products follow cGMPs and SOPs.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

Responsibilities

•    Develop annual audit schedule, coordinate supplier audits, and report on supplier audit schedule adherence
•    Ensure supplier files and database are current and accurate
•    Author, review, or revise Supplier Quality procedures and associated records/documentation
•    Complete assignments within department cycle times and maintain a high level of quality detailed documentation
•    Conduct internal audits of the site quality system to ensure documentation, practices, and procedures follow SOPs and cGMPs, review progress toward closure of audit finds and communicate the results of internal audits to appropriate management
•    Perform follow-up on all internal deviations and CAPAs
•    Interpret trends in audit findings and develop a proactive response to trending issues
•    Establish strategies and provide the leadership necessary to accomplish department goals while following all SOP and GMP guidelines
•    Investigate product complaints and perform mock recalls to verify compliance and readiness.
•    Perform SOP and cGMP training as required, track and trend training assignments and overall effectiveness of the training program

Qualifications

•    BA/BS Degree in a relevant field and 3 years of related work experience
OR
•    MA/MS Degree in a relevant field and 1 year of related work experience

Knowledge, skills and abilities

•    Working knowledge of quality system requirements such as US FDA, GMP, EMA and ICH guidelines
•    Excellent interpersonal, verbal and written communication skills Excellent organizational skills and an ability to prioritize effectively 
•    Ability to function independently or in a larger cross-functional group
•    Must be detail oriented, able to work in a fast-paced environment

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer.