Batch Record Reviewer

Batch Record Reviewer – Contract – Princeton, NJ – $45.00-$55.00/ Hr.
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Batch Record Reviewer in Princeton, NJ.

Role Description

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.

Skills & Requirements

• Highschool diploma or another equivalency (GED) is required. Bachelors degree preferred.
• 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.

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

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Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information. #1142815

Summary

Job Type
Contract
Industry
Technology & Internet Services
Location
New Jersey
Specialism
Other/TBC
Pay
$45.00-$55.00/ Hr.
Ref:
1142815