Columbia Consulting Group Hiring for Record Batch Reviewer at Summit, NJ Full Time

PURPOSE AND SCOPE OF POSITION:
The role of a Batch Record Reviewer is to review and release of manufacturing batch records and any/all records used at the CAR T manufacturing and testing facilities. Additionally, the reviewer is to collect information from triage and initiate the record in the Quality Management System (QMS) with the applicable information. These responsibilities must be done in a timely fashion in accordance with policies, standards, procedures and Global cGMPs. A Batch Record Reviewer also must foster meaningful working relationships with several different departments.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Must possess an independent mindset.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
• Builds relationships internally within and with cross functional teams.
• Contributes to goals within the work group.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.
• Proficient in MS Outlook, Word, and Excel.
• Reviews executed batch records for documentation completeness and accuracy.
• Obtains any identified GMP/GDP batch record corrections from manufacturing personnel.
• Performs other assigned duties as may be required to meet company objectives.
• Communicates effectively with other departments within the organization and functions well within a team environment.
• Collect information from triage and initiate the record in the Quality Management System (QMS) with the applicable information
• Complete the required fields in eQRMS in the NOE section as applicable.
• Possesses strong attention to detail.
• Possesses good written and oral communication skills.
• Works diligently
• Proficient in MS Outlook, Word, and Excel.
• Possesses strong interpersonal skills and the ability to work well in a team environment.
• Possesses good time management skills and has the ability to coordinate multiple tasks efficiently.

WORKING CONDITIONS (US Only):
Employs are required to be available ever day on site. In our shared office space, designated seating arrangements are available for all Batch Record Reviewers. There will be sufficient lighting and temperature control regardless of season or time of day. Noise ideally is kept to a minimum in this shared environment to maximize your efficient and communication skills. Heavy lifting and other strenuous activities are unnecessary and should not be performed unless otherwise stated by your manager. Sitting for long periods of time is required for this position, however, at times employees may be obligated to walk to other departments for several reasons. These reasons are included (but not limited to): obtaining corrections, recovering logbooks, or acquiring batch records. Additionally, attending triage meetings and initiating records in QMS. nIt is recommended, but not required, to get up every hour or so for a short walk as defined in ergonomics training.

Job Type: Contract

Pay: $56.00 per hour

Schedule:

• 12 hour shift