The Manufacturing Compliance Specialist is responsible for ensuring root-cause analysis is conducted on investigations for Septodont Production in Cambridge in a timely and efficient manner. You will act as a production quality and technical resource/liaison while preparing, compiling and writing investigation reports for completeness, accuracy, and compliance. You will also ensure that established procedures are followed for all investigations and that corrective and preventative actions are implemented. You will also proactively work to identify and resolve compliance concerns or issues highlighted.
Key responsibilities include:
- Conducts investigations for deviations following existing procedures.
- Identifies and/or recognizes critical path for investigations leading to timely identification of root cause, corrective & preventative actions.
- Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.
- Works to facilitate, coordinate and investigate deviations with the relevant team and Subject Matter Experts (SME) to identify issue and root cause. Utilizes problem solving and root-cause analysis tools to facilitate the investigation.
- Notify appropriate leaders of validation, raw material, stability & in-process failures and ensure investigations are initiated and written as per existing procedure.
- Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Writes and reviews investigation reports for completeness and accuracy prior to approval by Department Manager.
- Conducts impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, etc.) and prepares recommendations for Department Managers.
- Works with production management to conduct compliance audits, identify concerns and formulate and implement solutions.
- Works with production management to improve operations compliance processes and systems.
- Prepare and maintain lists, including status and next steps of open investigations and compliance items for Cambridge Management.
- Review on-going progress on relevant open investigations with Production supervisors to ensure alignment.
- Project manages the corrective and preventative actions and assists in both implementation and follow-up
- University Degree in a related science.
- A minimum of 3 years’ experience in the pharmaceutical industry, Quality Engineering or QA/QC.
- Fluency in project management & Root Cause Correct Action Tools.
- Superior technical writing skills and abilities
- Facilitating cross functional teams
- Superior organizational, interpersonal communication skills
- Ability to manage time effectively
- Ability to work independently and manage multiple priorities in a fast-paced and changing environment
What we offer:
- Excellent compensation/benefits package.
- Bonus and reward programs
- Discounted gym memberships
- Programs supporting work life balance
- Employee recognition program
- Professional and personal development programs
- Social events and spirit days
We thank all candidates for their interest, however, only those selected for an interview will be contacted directly.