Quality Associate- Quality Operations

Amerisource Health Services, LLC; Columbus (OH); On-site; USD 26,000 - 32,000; Full time

Benefits offered by this job

Medical, dental, and vision care

Comprehensive wellness benefits

Training and development programs

Volunteer activities and mentorship

Job summary

Amerisource Health Services, LLC is seeking a QA Production professional to provide direction for daily QA and production activities. You will audit batch records, perform serialization tasks, and support product releases to ensure compliance and quality.

The role requires strong documentation skills, basic math, and effective communication to collaborate with multiple departments. A high school diploma or GED is required, with a focus on quality and safety.

Qualifications

• High school diploma or GED required.
• Strong reading and writing skills for compliance documentation.
• Basic math and measurement skills for production activities.
• Able to communicate clearly with team members and supervisors.
• Familiar with ERP systems and Microsoft Office.
• Ability to work independently in a fast-paced environment.
• Detail-oriented with strong organizational skills.
• Good problem-solving and troubleshooting abilities.

Responsibilities

• Provide direction to QA and Production activities.
• Audit batch records for accuracy and compliance.
• Perform serialization tasks to support production needs.
• Verify discrepancies in systems and correct them.
• Conduct in-process quality checks and cleaning validation swabbing.
• Escalate non-conformances and assist root cause analysis.
• Participate in internal audits and continuous improvement.
• Adhere to cGMP and safety regulations.

Skills

Reading and comprehension

Written communication

Problem solving

Mathematical aptitude

Interpersonal skills

Organization & detail orientation

Judgement & compliance

Independent work

Verbal communication

Computer literacy

Education

High school diploma or GED

Tools

ERP Systems

Microsoft Office (Outlook, Word, Excel)

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere.

Job Details

Shift: Monday-Friday 7:00am-3:30pm. Pay: $21HR.

Responsibilities

• Provides direction and guidance to daily QA and Production activities.
• Could include but not limited to the following activities: Audits production batch records throughout the packaging process for accuracy and compliance.
• Conducts final audit prior to submitting to Product Release.
• Performs serialization activities, including but not limited to sending print, releasing, suspending, and cloning a work order to support production needs.
• Verifies and corrects non-controlled product and packaging component discrepancies within the applicable systems.
• Ensures applicable deviations and supporting documentation is provided in the batch record.
• Performs Quality in-process checks as needed.
• Performs Specific Gravity testing and TOC analysis.
• Performs Cleaning Validation swabbing upon the request of the Stability department.
• Creates, Reviews and Updates WIs and SOPs applicable to daily activities.
• Escalates non-conformance issues during the production process to management and leads the root cause analysis of quality incidents, participates in investigation discussions, and drafts Unplanned Deviations prior to submitting it for management review.
• Actively engages in all technical training, as well as compliance and other training required as a member of the quality team.
• Works in partnership with supporting areas (Sampling, Label and Documentation, Production, Warehouse) to resolve issues and improve processes by participating in continuous improvement activities to increase efficiency and Team Member engagement in the production area.
• Participates on the site internal audit team representing QA Production.
• Adheres to all cGMP, safety regulations, and understands SOP's.
• Performs all other duties as assigned.

Education

Requires completion of a high school diploma, general education or GED.

Skills and Knowledge

• Ability to read and understand the English language for the purpose of reading documents, product labels and instructions.
• Must have good written skills for the purpose of accurately completing compliance documentation for production runs.
• In-depth knowledge of the function and basic problem-solving capabilities for the purpose of troubleshooting issues during production activities.
• Must possess basic mathematical skills.
• Strong interpersonal skills; ability to develop and maintain cooperative working relationships with others.
• Strong organizational skills as well as detail oriented.
• Ability to use good judgement in order to carry out detailed instructions.
• Ability to work independently and handle a variety of tasks simultaneously.
• Good verbal and written communication skills.
• Computer literate with ERP Systems, Microsoft Office (Outlook, Word, Excel) and computer-based training.

Work Environment

The work environment characteristics described here are representative of those a Team Member encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions: The noise level in the warehouse is generally noisy.

Physical Requirements

Physical activity requiring reaching, bending, kneeling, stooping, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing. Ability to lift up to 50 lbs. with assistance. Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus. Team Member is frequently required to stand, walk (or otherwise be mobile). Ability to deal with stressful situations as they arise.

What Cencora offers

• medical, dental, and vision care
• a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
• backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave
• training programs, professional development resources, opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more
• For details, visit https://www.virtualfairhub.com/cencora

Full time

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

Amerisource Health Services, LLC

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.