Documentation Coordinator Il

Documentation Coordinator Il
  • $16 - $23 per Hour
    HOUR
  • Temporary
  • Branchburg NJ, US Branchburg Somerset US 08876
Job Ref: JO000103154
Sector: Science
Date Added: 16 July 2020


DOCUMENTATION COORDINATOR II

QC Product Release Coordinator II

Due to COVID, phone interviews will be conducted if Skype video is not an option. Please include your candidate's phone # and email address (if Skype video) when you confirm the interview.

Summary: This position is responsible for, but not limited to, reviewing processing batch records for compliant completion of manufacturing batch records to determine all necessary requirements were met for final disposition of LifeCell products for final release. This position is required to support overall departmental needs such as data trending, audit SME support, documentation updates among other tasks.

Key Duties and Responsibilities:
o Review processing batch records for compliance with all specified requirements and procedures.
o Make final determination regarding suitability of LifeCell products for final release of a lot to Finished Goods and/or other dispositions, including rejections.
o Work closely with Manufacturing and Quality to resolve any discrepancies uncovered during batch records review.
o Generate Certificate of Conformances as deemed necessary.
o Initiate reworks when applicable for nonconforming product to ensure they are conforming
• Quarantine product as deemed necessary for identified non-conforming product.
• Complete transactions as deemed necessary for acceptable or non-conforming product.
• Compile and perform trending of issues encountered at batch record review to identify any drift in performance or potential issues.
• Confirm research consent for lots designated for marketing, research or validation purposes
• Investigate Non conformance and CAPA’s.
• Assist Supervisor with various projects and metrics as deemed necessary.
• Initiate change controls for the department. (ECO’s)

Job Qualification (Minimum Requirements):
• Ability to work in a team environment
• Must be able to manually maneuver carts and material handling equipment weighing up to 10 lbs. while wearing appropriate personal protective equipment

Education and Experience
• High School/Secondary School/ Equivalent
• Associate’s or bachelor’s degree preferred

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
• 3-5 years of experience in GMP environment.
• Familiar with AATB, ISO, FDA and other regulations and guidelines.
• Knowledge of Microsoft Excel, Microsoft Word, TrackWise and SAP.
• Experience in Quality, Science, Biologics or related field.
• LSS trained (preferred)

Minimum Qualifications:
• Ability to work in a team environment
• Must be able to manually maneuver carts and material handling equipment weighing up to 10 lbs. while wearing appropriate personal protective equipment

Will this position require driving?

No

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
16/08/2020 12:00:00
USD 16.00 16.00
Contact Consultant:
Jennifer Law

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