Summary:
This position supports Client'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 purposeful presence on the shop floor, electronic batch record creation, batch record review, SOP revision approval, work order approval, and quality approval of minor deviations and CAPA records.

Responsibilities:

• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring quality records to completion.
• The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Preferred Qualifications:

• Bachelor's Degree in 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.
• Solid understanding and application of aseptic behaviors and principles

Must Haves:

• Experience working with Quality Systems / QA
• Ability to perform GMP operations
• BATCH RECORD EXPERIENCE (MANUFACTURING BACKGROUND EXPERIENCE)
• Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science eld (strongly preferred)

Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.