Quality Investigator

Amerisource Health Services, LLC; Kentucky; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

Training programs

Mentorship programs

Job summary

Cencora seeks a Quality Investigator to perform regulatory-compliant investigations including customer complaints, root cause analysis, and CAPA actions. This on-site role is based at our Columbus, OH facility with some schedule flexibility.

The ideal candidate holds a BS in a relevant science or engineering field and at least 3 years in a cGMP environment, with knowledge of pharmaceutical packaging records and QA processes. Strong communication and attention to detail are essential.

Qualifications

• BS in a relevant Science or Engineering discipline.
• At least 3 years of experience in a cGMP regulated environment.
• Knowledge of pharmaceutical packaging records, processes and QA in pharma.

Responsibilities

• Perform quality assurance investigations and ensure GMP compliance.
• Produce written investigation reports with root cause, corrective actions, and disposition.
• Conduct complaint investigations and maintain records of customer complaints.

Skills

Critical thinking

Attention to detail

Communication skills

Education

BS in science or engineering

Tools

MS Word

Excel

ERP

Job description

Job Details

Shift Hours: Monday- Friday 7:00AM-3:30PM Please note, flexibility in schedule will be required based on business needs, this can include working different hours or days.

Location: This position is located onsite at our facility in Columbus, OH. There is no option for remote or hybrid work.

The Quality Investigator is responsible for performing investigations to ensure they meet regulatory requirements. In addition, the Quality Investigator will investigate customer complaints and develop appropriate communications to the complainant. This job position is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.

Duties and Responsibilities

• Responsible for Quality Assurance Investigations at ABC and ensuring adherence to applicable GMP regulations and policies and procedures.
• Produces written reports that summarize the investigation, root cause determination, corrective actions and recommended disposition of affected product.
• Conducts complaint investigations and maintains records of customer complaints.
• Works with Production/QA to initiate investigations and minimize production down time.
• Assists with the development of appropriate corrective actions.
• Works with quality management to determine appropriate disposition of affected product.
• Maintains the Investigation/CAPA Database and other databases as required.
• Assists on follow-up checks on the effectiveness of corrective actions.
• Performs other duties as assigned.

Experience and Education

• BS in relevant Science or Engineering discipline.
• At least 3 years of experience in a cGMP regulated environment.
• Must have a working knowledge of pharmaceutical packaging records, process and equipment; and experience in quality assurance in the pharmaceutical industry.

Minimum Skills and Abilities

• Strong critical thinking and deductive reasoning skills.
• Strong oral, written, communication, presentation and interpersonal skills.
• Ability to interact with Regulatory Agencies, vendors and all levels of associates within the organization, including management and plant associates.
• Knowledge of QA principles, concepts, systems industry practices and standards.
• Ability to work independently.
• Ability to handle a variety of tasks simultaneously.
• Attention to detail.
• Strong skill in computer operations, experience with MS Word and Excel, ERP.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Equal Employment Opportunity

Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: Amerisource Health Services, LLC

Company Overview

Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them. We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.