Job Details:

Responsible for supporting Sentry’s Quality Management System (QMS) in accordance with established standards and regulations. This position involves collaborating with cross-functional teams to drive continuous improvement in product/service quality, resolve document-related quality issues, and maintain documentation to meet regulatory requirements.

Essential Duties & Responsibilities:

  • Organize, scan, label, file, and retrieve incoming/outgoing documents supporting multiple sites in a timely and effective manner in compliance with Sentry’s quality system and applicable regulations (e.g., 21 CFR Part 210 & 211, Standard Operating Procedures (SOP), and Client Operating Protocols (COP), etc.).
  • Support Manufacturing Operations by acting as a performer or verifier for labeling and packaging operations.
  • Support the authoring, review, approval, organization, and maintenance of GMP and non-GMP records.
  • Support the authoring, revision, review, organization, and maintenance of SOPs, COPs, or training material.
  • Facilitate departmental meetings and compose minutes.
  • Track and maintain departmental schedules, Key Performance Indicators (KPI), and outstanding action items.
  • Support internal, Client, and regulatory audits/inspections.
  • Create and/or control a document inventory process.
  • Perform additional duties as assigned by supervisor/manager.

Competencies

  • Workload planning, exceptional organizational skills, and the ability to continually evaluate and reprioritize workloads.
  • Excellent attendance and punctuality during normal business hours.
  • Self-motivated and require little direction or supervision.
  • Ability to multi-task.
  • Effective time management when dealing with and working under time constraints and other pressures associated with performing all aspects of this job.
  • Detail oriented.
  • Knowledge of GMP regulations and reporting requirements.
  • Embraces change and is dedicated to continuous improvement. Consistently searching for more efficient and effective ways to improve processes and procedures.
  • Ability to understand basic job functions and relate those to other job categories within the company.
  • Excellent verbal and written skills with all levels of the organization and ability to develop rapport with other members within the company.
  • Drives results through personal initiative and perseverance.
  • Excellent teamwork and collaboration skills.

Education and/or experience

Required: High School Diploma or GED required; experience in pharmaceutical, biotech, or other FDA-regulated industry preferred.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts. The employee is frequently exposed to cold/freezing conditions. The employee is occasionally exposed to high, precarious places; fumes or airborne particles; outside weather conditions; heat and vibration. The noise level in the work environment is within OSHA regulations.

Location: Indianapolis, IN

Department: Quality Assurance

Schedule: Full Time, On-Site

Education: High School Diploma or GED (Required) 

Experience: Pharmaceutical, Biotech, or other FDA-Regulated Industry