Quality Assurance Specialist - ROI Search Group

We are seeking a Quality Assurance Specialist to join a Fishers, IN, manufacturing organization providing world-class systems, processes, and services for the Pharmaceutical and Healthcare industry. This position is full-time and 100% on-site in Fishers five days per week and operates in a 24/7 environment. Therefore, the Quality Assurance Specialist must live in the Indianapolis area and be flexible as needs require.

The Quality Assurance Specialist will execute and carry out assigned quality assurance processes to ensure they follow the Quality Management System (QMS) relevant regulations and customer specifications as directed by their supervisor in a manufacturing environment. In addition, the Quality Assurance Specialist will support the manager in implementing and enhancing quality systems, promoting system consistency, providing technical training to relevant teams, and ensuring all documents, guidelines, directives, and procedures comply with the Quality Management System and applicable standards.

Resumes may be submitted directly or via email to hr@roisg.com.

Responsibilities:

• Ensures timely completion of all quality assurance tasks, maintaining compliance with applicable standards and requirements.
• Manages the final batch release process and provides product conformity certificates, collaborating with internal teams and external parties to support issue resolution, in line with standards and the Quality Management System (QMS).
• Manages deviations, CAPAs, and corrective actions by working with the Quality Control team, performing thorough investigations, and coordinating with internal functions and third parties to resolve issues effectively.
• Meets assigned targets by applying the site’s Quality Management System, including quality directives, regulations, and customer specifications efficiently and effectively.
• Supports the manager in ensuring compliance with Good Manufacturing Practices (GMP) for systems, lines, and equipment, collaborating with relevant functions.
• Handles all tasks related to managing audit sessions and customer technical meetings, delivering services and precise responses regarding assigned processes.
• Implements approved QMS documentation, including procedures, work instructions, CAPA, corrective actions, and deviations, and offers actionable feedback to the manager for improving or adjusting operating procedures.
• Supplies accurate and current information on regulations, standards, and customer requirements to other involved functions.
• Participates in training sessions to ensure required skills and awareness and provides technical support to other teams on quality issues.
• Prepares timely reports to analyze and monitor relevant KPIs, addressing and anticipating continuous improvement initiatives.
• Implements approved preventive and corrective actions to maintain process alignment and drive ongoing improvement.

Experience:

• Bachelor’s degree preferred; will consider equivalent work experience in lieu of degree.
• 2+ years of experience in a manufacturing environment working in Quality Assurance.
• Proven experience applying global manufacturing practices, including local regulatory requirements, current Good Manufacturing Practices (cGMP), and ISO standards.
• Proficient in QMS processes, features, and techniques to ensure compliance and continuous improvement within the quality framework.
• Knowledgeable in document management processes, features, and techniques to maintain accurate and organized documentation.
• Proven experience in project management and risk management methodologies, techniques, and tools for effective project execution and risk mitigation.

 Benefits:

This position offers a competitive salary with performance-based bonus along with comprehensive health insurance coverage, including dental and vision. In addition, the organization offers a retirement plan with generous matching and life insurance coverage. Recognizing the need for work life balance, the company offers paid holiday, vacation time, and PTO hours to their team members. Employees are eligible for other benefits including but not limited to short-term disability insurance, long-term disability insurance, flexible savings accounts, etc.

About ROI Search Group:

ROI Search Group is a woman-led staffing firm based in Fishers, IN. We provide comprehensive staffing solutions including direct hire, contract, and contract-to-hire in addition to other specialized and executive searches. Our unique methodology enables us to attract top talent and support candidates' career progression, aligning with our clients' and candidates' priorities to create mutual success.

At ROI Search Group, we are committed to fostering a workplace that values and celebrates diversity. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. We embrace the principles of equal employment opportunity and encourage all qualified candidates to explore career opportunities with us. We believe that a diverse and inclusive workforce enhances our creativity, innovation, and overall success. Join us in our commitment to equality and opportunity.