Quality Investigator

About the job

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

Schedule

Full time
Affiliated Companies
Affiliated Companies: Amerisource Health Services, LLC
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 hrsc@cencora.com . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned