Quality Operations Associate

Summary:

Reporting to the Manager of Quality Assurance, the QA Associate - Quality Operations provides guidance and direction to daily Quality and Production activities to maintain compliance with corporate and regulatory requirements. 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 Team Members responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately.

Work hours: Sunday - Friday -- 11pm -7:30 am EST

Primary Duties and 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

Required Skills and Qualifications:

• Requires completion of a high school diploma, general education degree (GED) or equivalent combination of experience and education

• Requires five or more (5+) years of equivalent work experience. Familiar with quality assurance concepts, practices and procedures in packaging of pharmaceuticals

• 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 and Mental Requirements:

• The physical demands described here are representative of those that must be met by Team Member to successfully perform the essential functions of this job

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

• 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

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

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