Quality Assurance Specialist

Payrate:

$30.00 - $33.00/hr.

This position supports Company's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of their processes, procedures, and use of quality systems. Duties include presence on the shop floor, electronic batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records.

• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records, including Process and Equipment Validation Documents to completion.
• The QA Specialist will also represent QA
  
  Functional area
  
  in the execution of projects necessary to achieve departmental operational goals.

• Bachelor's Degree in Engineering, Biochemistry, Biology, Chemistry, or related science field.
• Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices.
• Experience managing projects through to completion meeting timelines.
• Evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems. Strong organizational skills and ability to manage multiple tasks at one time.
• Effective communication skills (both written and verbal).
• Demonstrated ability to work as both a team player and independently.
• Display leadership attributes and drive improvement initiatives.

• Experience in and knowledge of GMP/GCP operations or similarly regulated industry.
• Affinity with digital innovation, data sciences and Quality engineering.
• Highly effective verbal and written communication skills, strong interpersonal skills.
• Great attention to detail and high degree of accuracy in task execution and GMP documentation.
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.

The typical base pay for this role across the U.S. is: $30.00 - $33.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.