Quality Assurance Specialist - Grand Rapids, MI | Biospace
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Quality Assurance Specialist

Corium International, Inc.

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Location:
Grand Rapids, MI
Posted Date:
11/22/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Compliance, Operations, QA, Quality, Quality Assurance, Regulatory Affairs,

Job Description

The Quality Assurance Specialist is responsible for supporting Quality Assurance operations, compliance, systems, and regulatory affairs functions.  

Essential Duties:

An employee in this position must be able to perform the essential job functions listed below with or without reasonable accommodation.  The Company will make reasonable accommodation for a qualified individual with a disability to enable the qualified individual to perform essential job functions.
Quality Assurance has multiple areas of responsibilities which may include Operations, Compliance, Systems, and Regulatory Affairs.  Each team member may be asked to focus on one area or work within multiple areas of Quality Assurance.

•   QA Operations: Uses technical, regulatory, and cGMP knowledge to provide oversight to the Manufacturing Operations, for both commercial and development projects.
    1.   Lead and participate as a team member in investigations (DEV, CA/PA).
    2.   Review executed operations records. Identify and reports errors or omissions.
    3.   Review documentation and release raw materials, WIP, and finished goods to next processing stage.
    4.   Provide troubleshooting and guidance to manufacturing shop floor employees on quality issues.
    5.   Assemble and issue batch records to Manufacturing.
    6.   Serve as a Quality Assurance liaison to internal and external customers for development and commercial products.

•   QA Compliance: Uses technical, regulatory, and cGMP knowledge to provide compliance oversight to the all Operational areas.
    1.   Complete in customer complaint investigations.
    2.   Perform internal and supplier cGMP compliance audits and DEA compliance audits.
    3.   Manage the Supplier Quality Management system.
    4.   Lead and participate as a team member in investigations (DEV, CA/PA).
    5.   Complete DEA inventory reports.
    6.   Serve as Quality Assurance liaison to internal customers.

•   QA Systems: Uses technical, regulatory, and cGMP knowledge to provide oversight to the Quality Management System.
    1.   Lead and participate as a team member in investigations (DEV, CA/PA).
    2.   Serve as liaison to internal customers.
    3.   Maintain and manage change control process according to established SOPs.
    4.   Review change control requests to insure documents meet company standards.
    5.   Maintain the training system.
    6.   Organize and manage document storage and retrieval process, maintain document log system.
    7.   Develop and improve QA systems and processes.
    8.   Maintain document log system.

•   Regulatory Affairs: Uses technical, regulatory, and cGMP knowledge to maintain and execute the regulatory affairs systems for both commercial and development projects.
    1.   Assemble documents to support FDA submissions, supplements, deficiency responses, and annual product reviews for review and approval.
    2.   Serve as liaison with internal and external customers.
    3.   Lead and participate as a team member in investigations (DEV, CA/PA).
    4.   Manage the regulatory filing system.
    5.   Review and remain current with FDA and other regulatory body regulations and guidance documents and determine applicability.
    6.   Identify and lead continuous improvement initiatives.

•   Ability to meet physical demands and perform the essential job functions within the work environment identified in this job description.

•   Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Requirements

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable qualified individuals with disabilities to perform essential functions.

Physical Demands:

While performing the duties of this job, the employee must be able to:
•   Remain in a stationary position extended periods of time, whether sitting or standing, and be able to move about inside the office to access file cabinets, office machinery, etc.
•   Operate a computer and other office productivity machinery, such as a calculator, copy machine and computer printer.
•   Communicate and exchange information with team members and other internal personnel and must be able to effectively communicate accurate information with external contacts.
•   Occasionally move and/or lift objects up to 25 pounds.
•   Occasionally climb stairs, bend, squat, kneel, crouch, and reach in any direction including above the shoulder to access materials and/or documentation.

Work Environment:

•   While performing the duties of this job, the employee is regularly working in a typical interior/office work environment.
•   Requires wearing OSHA and FDA approved protective and safety equipment in designated areas.
•   Position may involve extended work hours.
•   The noise level in the work environment is usually moderate.


Required Skills
•   Ability to maintain accurate records
•   Strong attention to detail
•   Comprehensive knowledge of Quality Assurance principles, FDA cGMP regulations, FDA guidance documents, and/or regulatory submission requirements


Required Experience
•   Bachelor’s degree in science discipline
•   Minimum of 2 years related experience preferred