Specialist, Quality Assurance

Cencora, Inc.; Columbus (OH); Presencial; USD 24.000 - 34.000; Jornada completa

Descripción de la vacante

Cencora, Inc. in Columbus, OH is seeking a QA/Production team member to oversee daily QA and production activities.

The role requires attention to batch records, compliance, and close collaboration with cross-functional teams to ensure product quality. The successful candidate will audit records, perform serialization tasks, and assist in investigations and deviations as part of our continuous improvement initiatives, while adhering to cGMP and safety standards.

Formación

• Requires high school diploma, GED or equivalent.
• Ability to read and understand English documents and labels.
• Good written skills for accurate compliance documentation.
• Basic mathematical skills for production checks.
• Strong interpersonal and organizational abilities.
• Good verbal and written communication across teams.
• Proficient with ERP systems and Microsoft Office.

Responsabilidades

• Provide direction and guidance to daily QA and production activities.
• Audit production batch records for accuracy and compliance.
• Conduct final audit prior to Product Release.
• Perform serialization tasks to support production needs.
• Verify and correct discrepancies in products and packaging components.
• Escalate non-conformance issues and assist root-cause analysis.
• Participate in site internal audits and continuous improvement efforts.

Conocimientos

English reading

Written communication

Mathematical skills

Interpersonal skills

Organizational skills

Verbal communication

Computer literacy

Educación

High school diploma or GED

Herramientas

ERP Systems

Microsoft Office (Outlook, Word, Excel)

Descripción del empleo

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.8.
• 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

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

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

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.