Job Details:
Associate I, Quality Assurance is responsible for supporting and implementing Quality Assurance processes, systems, and procedures to ensure compliance with industry standards and regulations while providing operational support (that does not conflict with Quality oversight). This position involves collaborating with cross-functional teams to drive continuous improvement in product/service quality, resolve quality-related issues, and maintain documentation to meet regulatory requirements.
Essential Duties & Responsibilities:
- Provide daily direct quality oversight of warehouse activities and documentation in compliance with quality system and regulations (e.g., 21 CFR Part 210 & 211, Standard Operating Procedures (SOP), Client Operating Protocols (COP), etc.). Examples include:
- Perform independent verifications of incoming or outgoing Client material.
- Review warehouse records prior to filing.
- Support Manufacturing Operations by acting as a performer or verifier for labeling and packaging operations.
- Author, review, and/or approve GMP and non-GMP facility records (preventative maintenance, pest control, facility walk throughs, etc.).
- Assist in the authoring, revision, and review SOPs, COPs, or training material.
- Support internal, Client, and regulatory audits/inspections.
- Participate in Corrective and Preventive Action (CAPA) processes to address audit findings.
- Participate in deviation and investigation reports related to Quality system failures and determine root cause.
- Assist in providing training to staff on quality-related procedures and standards to ensure a consistent understanding of quality requirements.
- Periodically carry on-call phone and respond to after-hour alarm situations.
- Additional duties as assigned by manager.
Competencies:
- 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.
- Workload planning, organization, prioritization.
Education and/or Experience:
Required: BA or BS in a science/technical field; three (3) years of QA/QC experience in a pharmaceutical, biotech, or other FDA-regulated industry; or a combination of both. |
Location: Indianapolis, IN
Department: Quality Assurance
Schedule: Full Time, On-Site
Experience: 3 Years of QA/QC in Pharmaceutical, Biotech, or other FDA-Regulated Industry
(Required)
Education: BS or BA in Science/Technical Field
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