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Title

QA Associate 3 

Description

SUMMARY:

This position is primarily responsible for issuance and review of Batch Manufacturing Records and to support Quality management systems.

EDUCATIONAL QUALIFICATION:

Four-year college degree or master degree; and/or seven to nine years related experience and/or training; or equivalent combination of education and experience.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Ensures compliance with cGMP, Company SOPs and FDA requirements during all phase of operations.

Issuance, assembly and auditing of batch records to assure all regulatory and internal requirements for the product quality including verification of calculations associated with formulation, and overall review of documents for cGMP compliance.

Prepare Packaging Specification for particular Batch Manufacturing Lot.

Review /Approve Master Packaging Specification and Packaging Batch Record

Prepares and maintains change control records, customer complaint investigation report.

Prepares and maintains mock recall records.

Conducting cGMP training for new hires and to prepare and maintains annual cGMP training records.

Reviews and approves of product releases as well as releases in Syspro System.

Prepares and maintains testing requisition record for Purified water analysis.

Prepare /Review Planned Deviation or Unplanned Deviation.

Prepare and maintains Finished Bulk Specification and Master Production Record, as a Backup.

Maintain Annual Product Review records for OTC products.

Monthly Audit of Warehouse 39 and Warehouse 41.

Maintains logbooks record.

Perform other duties as assigned.

Our jobs come with great benefits - including healthcare and ways to save for the future-

  • Competitive wage
  • Healthcare (medical, dental, vision, prescription drugs)
  • Network of Support (health & well-being on and off the job)
  • 401(k) savings plan
  • Paid Time Off (PTO)
  • Holiday pay
  • Employee discounts
  • Basic life insurance
  • AD&D insurance
  • Company-paid Short-Term and Long-Term Disability
  • On-the-job training and skills development
  • Employee Assistance Program
  • Tuition reimbursement
 
Position Requirements  
Full-Time/Part-Time Full-Time  
Aspire Website  
Position QA Batch Card Reviewer  
Number of Openings 1  
Number Filled 0  
Exempt/Non-Exempt Non-Exempt  
Location Aspire Pharmaceuticals Inc.  
About the Organization Aspire Pharmaceuticals is a global leader in soft gelatin manufacturing. Our stringent procurement operations backed with rigorous analytics and testing infrastructure provides custom solutions for our clients from concept to delivery. We are here to guide our clients to innovate better all while optimizing their product journey. As industry trailblazers we are constantly looking to think beyond the status quo.



As a leader in the development and manufacturing of soft gelatin nutritional supplements, we take that role with pride. Our singular vision starts with a question. How can we do it better? This sense of wonder is our driving force to create the highest quality products in the industry. No matter how the process starts, we always go through extensive testing studies, and refinement resulting in a superior encapsulated product.



Innovate. Formulate. Encapsulate. As our mantra suggests we are focused on innovation. We strive to revolutionize soft gel manufacturing and are determined to always be improving our own capabilities- from enhancing our cGMP lab to employing the use of robotics and vision camera inspection on the production floor. As a center of excellence for encapsulation we know how to consistently optimize the process all while providing our clients with the best possible products.

 

This position is currently not accepting applications.

To search for an open position, please go to http://AspirePharmaceuticalsInc.appone.com



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