Quality Specialist - Batch Records

Company: Collabera
Location: Wilson
Posted on: May 21, 2025

Job Description:

About the Role:

Apply below after reading through all the details and supporting information regarding this job opportunity.

We are seeking a detail-oriented and proactive Quality Assurance Specialist to support key QA functions, including batch record management, product release, SOP oversight, and regulatory compliance.
This individual will play a critical role in ensuring Good Manufacturing Practices (GMP) and maintaining quality standards in pharmaceutical manufacturing.

Pay Range: $40 - $45 an hr.

Key Responsibilities:

Perform batch record management tasks, including retrieval, archiving, scanning, and filing.


Complete batch record reviews and support release of intermediate and finished products for domestic markets.


Generate and provide Certificates of Compliance (CoC) and Certificates of Analysis (CoA) as needed.


Support internal and external audits by compiling relevant data and documentation.


Participate in investigations and quality issue resolutions.


Review and develop Standard Operating Procedures (SOPs) in compliance with GMP.


Provide Quality Assurance review and approval of GMP-related SOPs.


Manage Supplier Quality and additional QA-related documentation processes.


Oversee proper allocation and maintenance of the Document Retention room.


Assist with reconciliation of controlled print documents.


Track and process Registered Country Table (RCT) tender requests within SAP.


Contribute to continuous improvement initiatives and ensure adherence to regulatory expectations.



Qualifications:

Education:

Bachelor's degree (B.A./B.S.) in Science, Engineering, or a related field.




Experience:

Minimum of 3 years of experience in a GMP-compliant pharmaceutical manufacturing facility.


Hands-on experience in batch record reviews, documentation, product release, and quality systems.




Technical Skills:

Proficiency in SAP and Veeva Systems.


Knowledge of QA tools and compliance standards.




Soft Skills:

Excellent communication (written and verbal) and teamwork abilities.


Strong attention to detail and time management.


Ability to manage multiple tasks under pressure and meet project deadlines.


Skilled in identifying issues and implementing standard procedures for resolution.


Capable of working independently and making informed decisions using data and trending analysis.

Keywords: Collabera, Idaho Falls , Quality Specialist - Batch Records, Other , Wilson, Idaho