QA Specialist / Document Control Specialist

Ompi of America IncFishers, IN, US

job_description.job_card.variable_days_ago

serp_jobs.job_preview.job_type

serp_jobs.job_card.full_time

job_description.job_card.job_description

Job Description

About Company :

For more than 70 years, we have been committed to provide integrated solutions for pharma and healthcare, leveraging on constant investment and the acquisition of skills in new technologies.

A rich, international heritage has brought us to become a global player in the pharma industry, operating in 9 countries and exporting its products in 70 countries.

Today we are the market leader in the manufacture of cartridges for insulin pen injectors, the world’s largest manufacturer of pre-sterilized vials (EZ-fill®) and the world’s second-largest manufacturer of pre-fillable syringes.

About the Role :

The QA Specialist / Document Control Specialist at the Fishers Plant, FPL, plays a critical role in ensuring the highest standards of quality and compliance within the manufacturing environment. This position is responsible for managing and maintaining all quality assurance documentation, ensuring that all processes adhere to regulatory and company standards. The role involves close collaboration with production, engineering, and regulatory teams to support continuous improvement initiatives and audit readiness. The specialist will oversee document control systems to guarantee accuracy, accessibility, and security of quality records. Ultimately, this position ensures that all quality documentation supports the plant’s operational excellence and regulatory compliance objectives.

Minimum Qualifications :

Associate’s or Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or a related field.
Minimum of 2 years of experience in quality assurance or document control within a manufacturing or regulated environment.
Proficiency with document management systems and quality management software.
Strong understanding of quality standards such as ISO 9001 or equivalent.
Excellent organizational skills and attention to detail.

Preferred Qualifications :

Experience working in a manufacturing plant environment, preferably in the energy or utilities sector.

Familiarity with regulatory requirements relevant to the industry, such as FDA, EPA, or OSHA standards.

Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor) or Document Control.

Advanced skills in data analysis and reporting tools.

Demonstrated ability to lead quality improvement projects.

Responsibilities :

Manage and maintain the document control system, ensuring all quality-related documents are current, properly archived, and accessible to relevant personnel.

Review and verify quality assurance documentation for accuracy, completeness, and compliance with internal and external standards.

Coordinate with cross-functional teams to support quality audits, inspections, and regulatory submissions by providing required documentation and records.

Assist in the development, implementation, and continuous improvement of quality management system procedures and policies.

Track and report on quality metrics and document control activities to support management decision-making and compliance monitoring.

Skills :

The required skills enable the specialist to efficiently manage and control quality documentation, ensuring compliance and traceability throughout the production lifecycle. Strong organizational and communication skills facilitate effective collaboration with multiple departments and support audit readiness. Proficiency in document management systems allows for accurate tracking, updating, and retrieval of critical quality records. Preferred skills such as regulatory knowledge and quality certifications enhance the specialist’s ability to interpret and apply complex standards, driving continuous improvement. Analytical skills support the evaluation of quality data and the identification of trends, contributing to informed decision-making and process optimization.

serp_jobs.job_alerts.create_a_job

Qa Specialist • Fishers, IN, US