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Title

QA Associate  

Description

SUMMARY:

This position is primarily responsible for coordinating and directing quality assurance programs and reviewing, preparation/maintenance of SOPs, calibration and other controlled document to ensure accuracy, completeness, and adherence to establishment standards by performing the following duties.

EDUCATIONAL QUALIFICATION:

Four year college degree or master degree; and two to three 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.

Prepares of SOP's to help Implement Quality System at all levels within the organization

Maintains the records for calibration on process equipment, calibration on QA data logger and calibration on engineering equipment.

Maintains and oversees documentation control of all regulated documents.

Prepares and maintains record for change control, planned or unplanned deviation, customer complaint investigation report, mock recall, annual GMP training.

Generates regulated documents in line with the cGMP for Dietary Supplement 21 CFR 111.

Completes quality assurance operational requirements by scheduling or co-ordination with other departments.

Prepares and maintains record of testing requisition for water analysis.

Updates and maintains records including training, SOPs, Validation and Calibration.

Assesses incoming complaints and escalate issues that require QA Manager's immediate attention.

Executes and participate in internal and external audits.

Ensures that all Quality Systems, including CAPA, Complaint Handling, Deviations, Nonconforming Product, and Internal Auditing comply with FDA.

Follows up any task assigned by the QA Manager.

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 1  
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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