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Form of workJob Description
General Purpose of Position:This position is primarily responsible for collaborating with all departments to provide Quality support for all operational areas at Aprecia’s Blue Ash facility as well as help with creation of processes and procedures at Aprecia’s Blue Ash facility.Primary Duties and Responsibilities (Essential Functions): Duties/Responsibilities1Performs ‘Quality on the Floor’ duties, including supporting Manufacturing during production by providing guidance regarding established procedures and processes, participates in room and equipment clearances and other quality checks required during the manufacturing and packaging processes.2Perform review and release of all executed Manufacturing Batch Records and supporting documentation for completeness, accuracy, and compliance.3Review and approve test results from analytical laboratories and disposition raw materials and finished products.4Perform initial triage of deviations that occur during batch manufacture or packaging, demonstrating the ability to understand complex quality issues.5Participate in Cross-functional Root Cause Analysis meetings.6Provide quality oversight, document review and guidance for other departments.7Author/Review Standard Operating Procedures and other quality related GMP documents.8Models effective and constructive communication behaviors and interactions with all departments both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g., interpersonal) skills.9Assists with the development of CAPA and collaborates with stakeholders to ensure all necessary activities are executed timely and effectively.10Escalates critical events and investigation findings to Management.11Assist in developing and maintaining various quality systems and programs. May also represent the Quality Assurance group on various project teams such as validation, engineering phase
review meetings, and daily department communication meetings. 12Requires interaction with Manufacturing Operations, Operations Engineering, QA Management, Quality Control, Regulatory Affairs, EHS, IT, and Pharmaceutical Development and Technical Services.13Other duties as assigned.
Reporting to this Position:
No direct reports
review meetings, and daily department communication meetings. 12Requires interaction with Manufacturing Operations, Operations Engineering, QA Management, Quality Control, Regulatory Affairs, EHS, IT, and Pharmaceutical Development and Technical Services.13Other duties as assigned.
Reporting to this Position:
No direct reports
- Working knowledge of cGMP’s within the pharmaceutical industry
- Ability to manage multiple projects simultaneously
- Ability to learn and adapt to demands in a fast-paced work environment
- Must be able to manage and prioritize daily tasks with minimal supervision
- Strong written, verbal and interpersonal skills
- Ability to work in a hands-on collaborative fashion with many different disciplines both inside and outside of the company
- Strong problem-solving skills
- Ability to think conceptually and understand impact of decisions
- Good conflict resolution and negotiation skills
- B.S. degree in scientific discipline preferred or equivalent combination of education and experience
- Minimum of three (3) years of experience in the pharmaceutical industry required
- Minimum 2 years of experience working in Quality Assurance, preferred
- Ability to sit at desk for extended periods of time
- Extended viewing of computer screens and manual dexterity to operate office equipment
- Ability to perform minimal lifting (typically less than 25 pounds), walking, and physical exertion (bending, kneeling, twisting, climbing) specific to physical inventories and related work
- Good eyesight and critical thinking to read, create and interpret business documents and spreadsheets
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.
