Quality Assurance Analyst - GMP Investigator

Description

Position Summary: The Quality Assurance Analyst is primarily responsible for assisting in maintaining the Quality Management System on a local level. This includes, but is not limited to, assisting with product quality investigations/corrective and preventative actions, customer complaints, supporting audits, and other responsibilities as assigned in support of the Quality Management System. This position will also function as a back up for the local Hickory Quality Representative.

Essential Functions:

Coordinates Corrective and Preventive Action (CA/PA) efforts, including CA/PA initiation and assignment, follow-up activities with responsible managers, tracking for quarterly Management Review and verifying effectiveness of actions taken.

Collaborates with other functions in the organization on change control, risk assessments, and validation activities. Works with customers on protocol and report content, driving consistency.

Coordinates local the local Internal Audit program and associated follow-ups.

Coordinates the monthly GMP inspection program and associated follow-ups.

Supports the facilitation of Gusmers Good Manufacturing Practice program, collaborating with GMP team in plant audits, GMP reports, and program improvements.

Conducts root cause analysis and help drive implementation of corrective actions for process related concerns and Nonconforming Material situations. This may include data analysis and testing as part of the investigation.

Works with many employees from all sites and functions including maintenance, production, R&D, quality, engineering, warehousing, office, and management.

Assist with Customer Complaint reports, root cause analysis, and CA/PA efforts as needed

Other Duties

Support the document control and training as needed.

Perform final Quality Assurance review and release of finished product as needed

Provide support at Quality Council at both a site and corporate level.

Assists QC Lab functions as needed

Assists Supply Chain as directed, with incoming raw material issues/concerns.

Assists with investigational testing as needed, including L&E or device testing.

Performs other Quality Assurance Analyst duties as assigned.

Skills

• Quality assurance
• GMP
• Data
• Compliance
• CAPA
• FDA
• Batch record
• Investigation
• Root cause analysis
• Audit

Additional Skills & Qualifications

Bachelors Degree in life sciences, or equivalent experience preferred.

2 - 5 years of work experience in ISO9001 certified company or other highly regulated environments with some involvement in QMS.

Some six-sigma training preferred

Experience Level

Intermediate Level

Pay and Benefits

The pay range for this position is $23.00 - $26.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Hickory,NC.

Application Deadline

This position is anticipated to close on Aug 29, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email ... for other accommodation options.