Quality Systems Specialist
Quality Systems Specialist/Data Entry at Biotech/Pharma
Location: Cambridge, MA
Duration: 6 months
This data entry project will transition all open CMC Change Controls for seven commercial products at Biotech/Pharma & Biologics from TrackWise (EMS) into CATSWeb, the new Global EQMS.
Responsible for the accurate data entry of a total of 251 CMC Change Control records for Commercially distributed products from Biotech/Pharma Boston's legacy TrackWise Excursion Management System (EMS) (TrackWise) into the new harmonized Global Electronic Quality Management System (G-EQMS) for Biotech/Pharma (CATSWeb).
Responsible for the accurate data entry of CMC regulatory assessments and impacted markets from EMS into Biotech/Pharma Product Registration Information and Submission Management (PRISM) data entry form.
Responsible for collaborating with Biotech/Pharma Global Regulatory Affairs and Central Data Entry teams to ensure all submitted and approved markets are accurately and completely entered into PRISM and viewable in Global EQMS via the system interface.
Participate on a team of up to four (4) individuals under the direct supervision of the Associate Director of O&B Quality Systems (or designee), to accurately perform data entry of a total of 251 CMC Change Control records from the Legacy EMS (TrackWise) system into Biotech/Pharma recently harmonized Global Electronic Quality Management System (Global EQMS) (CATSWeb).
The Global EQMS interfaces with an application called PRISM (Biotech/Pharma) Product Registration Information and Submission Management system). A component of this data entry project will include mapping the current regulatory impact assessments from EMS to Events in PRISM, and ensuring that impacted markets and regulatory assessments are appropriately displayed in Global EQMS, after data entry into PRISM has been completed by Takeda???s Central Data Entry Team (CDET).
This individual works cross-functionally in a virtual setting, interacting routinely with members from O&B Quality Systems and Takeda Global Regulatory Affairs to meet assigned data entry tasks per project timelines accurately and completely.
Working hours: 8 AM - 5 PM
Completes data entry of legacy changes into Global EQMS and completes PRISM Data Entry form based on assigned weekly schedule, such that activities are conducted in a timely and efficient manner, project milestones are met, and GXP compliance is maintained.
Enters open legacy Commercial CMC Change Control records from EMS into Global EQMS for the seven (7) Commercial products for which TBOS either has quality responsibility for, or is the Market Authorization Holder.
Determines the impacted markets and associated regulatory impact assessments for each open legacy change and completes the PRISM Data Entry form with this information.
Ensures that the PRISM Data Entry form is reviewed by the applicable Global Regulatory Affairs representative for accuracy and completeness, prior to sending the form to the PRISM Support Central Data Entry team (CDET) for entry into PRISM.
Reviews communication back from PRISM team to verify that all markets have been entered and are reflected in Global EQMS, that filing types entered are accurate, and that the correct dispatch, submission and approval dates are reflected for each market.
Collaborates with PRISM Central Data Entry Team when applicable to ensure any corrections are made.
Verifies with Quality Systems contact that change is completely and accurately entered into Global EQMS.
Meets with individual employees and/or groups, both on site and or remotely on a regular basis to discuss data entry status, to prioritize, and assign work and projects.
Develops and maintains strong internal relationships with project team and cross-functionally, as needed.
Will not manage any employees
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Minimum BA/BS in any life science discipline
Must have minimum 2 years??? industry experience
Must have previous industry experience in a regulated environment, preferably a broad-based Quality and Regulatory background.
Must have Commercial Change Control experience, preferably with global products.
Must have excellent attention to Detail.
Must have excellent typing and data entry skills.
Must be dedicated to meeting committed timelines.
Strong computer aptitude.
Must be experienced in Microsoft Word and Excel. Knowledge of PivotTables a plus.
Experience with CATSWeb or TrackWise applications desired, but not required. Must be able to communicate effectively with employees, peers and management.
Ability to handle multiple tasks concurrently, and in a timely fashion.
Strong interpersonal skills and must be able to work effectively and efficiently in a team environment.
Must have the following personal attributes: integrity and trust, work ethic, sound judgement.
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