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Quality Assurance Manager

Blue Ash, Ohio
General Purpose of Position:
The position is responsible for managing the daily QA (Quality Assurance) operations to assure the quality of Aprecia Pharmaceuticals products.  This position is also responsible for the quality of products produced, tested, and packaged at the site. 

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Manage all QA operations and procedures to ensure that the assessment of raw materials, packaging materials, in–process products, and finished goods is performed consistent with cGMP (current Good Manufacturing Practices) and Aprecia Pharmaceutical standards
2 Escalate significant quality issues to Quality Assurance Director as necessary
3 Serve as the primary staging coordinator for regulatory visits – FDA (Food & Drug Administration), MHRA (Medicines and Healthcare products Regulatory Agency), etc., and participate in providing site response to FDA inquiries
4 Provide quality assurance management of discrepancies, minor deviations/planned deviations, Change Control closures and OOS/OOT investigations.  Also assures timely investigations and use of CAPA (corrective action/preventative action) system
5 Provide Quality Assurance management of personnel, work assignments for QA Auditors and Specialists and QA on-the floor activities to support manufacturing operations for all areas.
6 Work closely with direct reports and Quality Management to ensure that a consistent approach is taken in evaluation and resolution of quality issues
7 Responsible for QA support of Cleaning Validation activities, R&D Projects, and clinical supply coordination
9 Manage the site QA personnel through coordination of the manufacturing production schedule with time off requirements for vacations/holidays.

Reporting to this Position:
QA Auditors and QA Analysts

Travel:
Position may require 5% travel

Work Shift:
This position typically works days, but is responsible for supporting production across multiple shifts

Knowledge, Skills and Abilities:
  • Demonstrated ability to understand complex quality issues and drive scientifically sound and compliant resolutions
  • Excellent oral and written communication skills
  • Expert knowledge of cGMPs and FDA pharmaceutical regulations
  • Well-developed interpersonal and problem solving skills
  • Excellent leadership and organizational skills
  • Ability to effectively interpret and analyze data so that decisions can be made on product quality
  • Ability to effectively interact with the following internal and external contacts/customers:
    • Other site departments to address quality and cGMP compliance issues
    • Aprecia Pharmaceuticals groups (Materials, Operations Engineering, Purchasing, Regulatory Affairs, Quality Operations, Quality Control, R&D, and Manufacturing) to address cGMP compliance and outside contractor issues
    • Contractors, suppliers, and contract packagers to resolve quality issues
Education and Experience:
  • B.S. degree in a scientific discipline (e.g. chemistry, biology, microbiology, engineering), or equivalent combination of education and experience required
  • Minimum of five (5) years of experience in a QA role in the pharmaceutical industry
  • 1-3 years supervisory experience required
Physical Demands and Work Environment:    
  • Sitting at a desk for extended periods of time
  • Standing and walking for extended periods of time
  • Occasional lifting of boxes (5-10 pounds) containing documentation
  • Speaking and listening abilities to communicate with employees and external parties
  • Bending, kneeling, and other odd body positions while accessing files and performing other job duties
  • Manual dexterity to operate a computer for extended periods of time
  • Good eyesight to create, read, and interpret business documents and inspect product quality
  • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (i.e. respirators, over-gowning, gloves, steel toe shoes)


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, sexual orientation, gender identity, national origin, disability or veteran status.

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