732-661-0400

QA Associate (pharmaceuticals)

  • Location: Cincinnati, Ohio
  • Type: Contract To Hire
  • Job #35065

This function is responsible for final review of batch records prior to disposition of product and release of raw materials.  Functions include preparation of batch Certificates of Analysis, document review, TrackWise reporting, hold forms, discrepancy tracking. This function thresholds events to Senior Associate when they are outside of the area of responsibility.

The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations.  Works on problems of a diverse scope where analysis and problem solving is required.  Receives general oversight and guidance on approaches to complete project related tasks.  Applies job related skills and understanding of policies and standards in completing tasks.

 

Key Duties:

  • Evaluation of batch manufacturing records and testing records
  • Disposition of raw materials and bulk batches per associated specifications
  • Final review of batch records and generation of documents for finished product disposition
  • Review and approval of incident, Minor, and Major workflow deviations in Trackwise as the Quality Contact.
  • Review and close of Corrective and Preventive Actions in Trackwise as the Quality Contact.
  • Review and approval of Change Controls.
  • Review and approval of Raw Material and Finished Product Specifications.
  • Authority to approve written procedures and other documents
  • Develop Standard Operating Procedures and other quality related documents.
  • Follow-up on preventive and corrective actions associated with deviations, lab investigations and Environmental Excursions
  • Interact with plant personnel to insure CGMP compliance.
  • Provides back up for other QA and plant site personnel as appropriate.
  • The monitoring of compliance with the requirement of GMP

 

Preferred Skills/ Abilities:

  • Working knowledge of US Drug Product GMP requirements and associated guidelines
  • Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues
  • Ability to increase others knowledge of US end European GMP regulations and guidance
  • Strong written and oral communication skills
  • Experience in administration of quality systems for drug product manufacturing and quality control operations
  • Strong written and oral communication skills

 

Preferred Personal Attributes:

  • Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks
  • Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others
  • Good computer skills
  • Good work ethic, dependable, punctual, and flexible
  • Good motivator of personnel
  • Good team player with a can-do attitude
  • Can get things done on the basis of influence
  • Can work in a fast-paced environment with multiple issues open simultaneously
  • Highly organized
  • Attention to detail
  • Identifies opportunities to improve and contributes to problem solving

 

Required Education/ Experience:

  • Bachelor’s degree in a scientific discipline or equivalent
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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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