Position

Quality Assurance Specialist (Lynchburg, VA)


Department:

Quality Assurance

 

The role of the QA Specialist is to provide compliance support within the Quality Assurance department.  The responsibilities include, but are not limited to, conduct and support of the activities associate with site change control program, investigations, annual product reviews, stability program, auditing, CAPA, or document review.  The successful candidate must be flexible to work in one or more of the described functions and must possess strong cGMP knowledge and experience in quality assurance processes. 

 

Accountabilities

  • Compliance to cGMPs and Fleet’s procedures

Responsibilities

  • Support the change control process by assigning tasks to appropriate departments and reviewing completed tasks.
  • Prepare technical reports for Annual Product Reviews
  • Review reports and documents for compliance to GMPs and company procedures
  • Support QA investigations by gathering information through interviews and document review
  • Prepare investigation reports
  • Prepare supplier risk assessments
  • Prepare technical reports for annual product reviews
  • Help with internal audits
  • Help review supplier self-audit questionnaires for completeness and acceptability
  • Help with the stability program by preparing protocols and documentation review
  • Prepare Quality Agreements with suppliers and contract laboratories
  • Provide back-up support for controlled document issuance
  • Lead with good verbal and written communication skills during audit situations.
  • Update procedures for the department, as required
  • Manage escalation of quality issues to management and support resolution
  • Prepare monthly reports on time for key performance indicators
  • Follow cGMP and able to make decisions using cGMP/process knowledge
  • Support continuous improvement projects
  • Perform other related duties as required.

Health, Safety & Environmental

  • Ensure regulatory and corporate compliance.
  • Become trained in all Safety and PPE requirements
  • Lead by example.

Operational Performance

  • Ensure performance goals are met.
  • Ensure achievement of all unit Key Performance Indicators (KPIs).
  • Ensure compliance with corporate standards (e.g., financial, code of business conduct) and adherence to company policies.
  • Support business processes and requirements.

People Management/Development

  • We expect all employees to foster a culture that values diversity and promotes respect, inclusion, cooperation and responsibility in all aspects of the business.

Image removed.Qualifications

Minimum Education and Experience Requirements

 

  • Requires the knowledge gained through a Bachelor’s degree in technical or science related field, preferably chemistry or chemical engineering
  • Minimum of two years of quality assurance/control experience in a cGMP pharmaceutical industry

Skills, Knowledge and AbilitiesImage removed.

  •  
  • Requires strong proficiency in Microsoft Office products especially Word and Excel
  • Requires knowledge and understanding of inventory management systems
  • Ability to perform statistical and mathematical functions
  • Able to understand and apply company SOPs.
  • Strong written and verbal communication skills.
  • Able to work independently.
  • Must be capable of being crossed trained in activities within the department.

Prestige Consumer Healthcare (including Fleet Laboratories) is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics. Prestige Consumer Healthcare is also committed to protecting your privacy and any job application data you submit shall be processed by us pursuant to our Privacy Policy (you can access at https://www.prestigebrands.com/privacy-policy). By submitting your job application data, you consent to our processing of such information in accordance with our Privacy Policy.


Prestige is an Equal Opportunity Employer

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