Quality Assurance Manager

Shift Hours:

Sunday- Thursday 10:30PM- 7:00AM (or complete)

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.

This role is in support of American Health Packaging (AHP), a Cencora business offering pharma packaging services in the US.

Under direct supervision of the Sr. Manager - Quality Assurance, this role is responsible for the directing, leading, and mentoring of a team of Quality Assurance (QA) technicians and also works directly and effectively with internal key customers.

This role provides a high level of responsibility, accountability, visibility, and opportunity to influence AHP quality results.

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.

Role Responsibilities:

• Responsible for quality activities in each packaging room, coordinating with QA Packaging Technicians to direct activities in the packaging rooms, and maintain a regular visible presence on the floor.
• Has the overall responsibility for the performance of the QA Technicians, including quality, safety, and customer service on a given shift.
• Works closely with Operations Managers to ensure product produced meets all applicable standards.
• Maintains Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs) related to the quality of our packaging lines.
• Responsible for quality, operations, safety and security of the facility.
• Demonstrates an understanding and articulates to the team of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
• Support production to meet customer delivery requirements on time, first time, every time.
• Responsible for ensuring that daily quality and manufacturing targets are met.
• Participant and leader of project teams.
• Responsible for overseeing CI activities on assigned shift to promote improved efficiency and effectiveness of quality process, including completion of gap assessments and actions plans. Also includes oversight of 5S and other lean activities on the shift.
• Responsible for various record keeping activities including but not limited to batch records and shift reports. Competent in editing batch records and compiling constructive narrative information pertaining to batch production. Reviews batch record for completion and proper documentation.
• Excellent management skills to supervise personnel and interact with other departments at all organizational levels. Facilitates team meetings and reviews.
• Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
• Creates an environment of inclusion and engagement.
• Inspects and releases quarantined packaging material or rejects. Inspects finished drug product and verifies reconciliation of labels and inserts.
• Over sees and performs on-the- job quality training.
• Assists in performance management review programs.
• Responsible for the hiring, training, development, and mentoring of QA Technicians. Coordinates shift staffing with Sr. QA Manager and other leadership personnel.
• Completes accident/incident reports and conducts investigation. Participates in follow-up meetings and CAPA.
• Assists in writing/revising and maintaining task, department, and general SOPs.
• Reviews and approves associates time and attendance for payroll. Approves/Denies time off request, ensuring that staffing is maintained appropriately to allow for Safe and Quality focused production to meet business demands.
• May provide backup coverage for other managers as needed.
• May be required to work various shifts, hours and weekends.
• Performs related duties as assigned.

Education and Experience:

• Requires a bachelor's degree with at least five (5) years of experience in the Quality field or equivalent combination of experience and education.
• A minimum of one (1) year experience in leading and directing the work of others.
• Previous project management experience is preferred.

Skills and Abilities:

• Ability to lead and manage teams.
• Ability to communicate effectively both orally and in writing.
• Ability to develop and maintain cooperative working relationships with others across all levels of the organization.
• Strong organizational skills; attention to detail.
• Proven experience successfully managing projects
• Ability to resolve issues effectively and efficiently
• Strong problem solving skills
• Ability to use good judgment in order to carry out detailed instructions.
• Ability to work independently and lead others.
• Ability to handle a variety of tasks simultaneously.
• Ability to make decisions and implement changes as directed.
• Strong computer skills including intermediate to advanced skills in MS Office software.
• Experience with document control software is preferred.
• Intermediate understanding of KPIs for quality manufacturing operations.
• Strong knowledge of cGMP Regulations Part 210/211 and 820 as well as DEA regulations.
• Knowledge and understanding of pharmaceutical production and quality concepts and procedures is required.

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