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Quality Analyst I

Blue Ash, Ohio
General Purpose of Position:
This position is primarily responsible for providing Quality support for manufacturing operations.

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Perform review of GMP documentation including manufacturing and packaging batch records, manufacturing logbooks, material specifications, and other quality documentation as assigned.
2 Assist with ‘QA (Quality Assurance) on the Floor’ duties, including support for Manufacturing during production by providing room inspection and clearances, equipment inspection and clearances, and other quality checks required during the manufacturing and packaging processes.
3 Review and approve test results from analytical laboratories.
4 Writing and reviewing standard operating procedures and technical documentation for the storage, manufacture, testing, and distribution of products manufactured.
5 Provide quality oversight, document review and guidance for other departments.
6 Support other areas of Quality Assurance including Quality Systems and Quality Control, as designated by management.
7 Participate in internal audits of other departments as a member of the audit team.
8 Other duties as assigned.

Reporting to this Position:
None

Travel:
None

Work Shift:
Primarily day shift M-F, however responsibilities for this role may require coverage across non-routine working hours, if required to support production needs.

Knowledge, Skills and Abilities:
  • Strong oral and written communication skills
  • An understanding of cGMPs (current Good Manufacturing Practices) and FDA (Food and Drug Administration) pharmaceutical regulations
  • Developed interpersonal and problem-solving skills
  • Time management and organizational skills
  • Skilled at using MSOffice
Education and Experience:
  • B.S. degree in scientific discipline preferred
  • Minimum of one (1) to two (2) years of experience in the pharmaceutical industry preferred
  • Experience working in a quality-related role, preferred
  • Previous experience working in a pharmaceutical manufacturing or laboratory setting
Physical Demands and Work Environment:    
  • Ability to sit at a desk for extended periods of time
  • Ability to stand and walk 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, keyboards, and other general office equipment
  • Good eyesight to create, read, and interpret business documents
  • 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, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.

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