QA Support/document Specialist

Documentation Specialist/QA Support

This individual plays a vital role in performing and assisting in coordinating resource allocation to conduct stability administration activities, ensuring accuracy and compliance against pre-defined standards and specifications. This role is essential for maintaining the integrity of all records in accordance with cGMP requirements and providing effective coordination and support for both external and internal audits.

Responsibilities

Organizing and Tracking Samples:

• Help manage and schedule stability tests (how products hold up over time).
• Make sure everything is done accurately and on time.

Handling Paperwork and Records:

• Keep track of documents and make sure they follow strict rules (cGMP).
• Store and manage records properly so they're easy to find and audit.

Supporting Audits:

• Help prepare for inspections from internal teams or outside agencies.
• Make sure everything is in order and compliant.

Monitoring Product Stability:

• Track how products perform over time (Real Time Stability).
• Spot trends or issues using basic data analysis.

Reporting Issues Quickly:

• If something goes wrong (like a failed test), report it in the system within one business day.

Helping Improve the Lab:

• Take part in projects to make the lab run better or more efficiently.

Keeping the Workplace Safe:

• Follow safety rules while making sure the work meets quality standards

Essential Skills:

• Proficiency in laboratory operations.
• Experience with audit processes.
• Knowledge of stability testing and document control.
• Ability to track follow-up activities associated with Real Time Stability.
• Skill in trending and statistical analysis of stability data.

Additional Skills & Qualifications:

• Experience with resource allocation to conduct stability administration activities.
• Capability to ensure accuracy and compliance against pre-defined standards and specifications.

Work Environment:

The Laboratory Associate will work in a laboratory/office environment. The schedule is Monday to Friday, 8 AM to 5 PM.

Pay and Benefits:

The pay range for this position is $17.00 - $18.00/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 Ormond Beach, FL.

Application Deadline:

This position is anticipated to close on Sep 17, 2025.