Product Quality Specialist

Description:

Aditi Consulting is seeking a Product Quality (PQ) Quality Assurance Specialist to support its Product Quality team as a subject matter expert in quality system records. This role involves collaborating across Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality, and Process Development to drive projects, resolve issues, and manage investigations.

The selected candidate will play a critical role in ensuring compliance and product quality through ownership, review, and approval of key documentation, including product specifications, technical reports, in-process control specifications, annual product reviews (APRs), change control records, deviation investigations, CAPAs, analytical comparability protocols/reports, and other supporting documentation.

Responsibilities also include executing transactions in GMP systems such as Veeva CDOCs and Trackwise, supporting audits, and contributing to annual product review cycles. The QA Specialist will be expected to work independently, leveraging strong technical and project management skills to maintain compliance with GMP and regulatory requirements while guiding cross-functional teams toward effective resolution of quality matters.

Qualifications:

• Bachelor’s degree in Biochemistry, Chemistry, Biology, Biotechnology, or a related field (or equivalent biopharmaceutical experience).

• Strong understanding of GMP regulations, pharmaceutical quality compliance, and regulatory practices.

• Prior hands-on experience with Veeva, Trackwise, and other quality systems.

• In-depth knowledge of biopharmaceutical development, manufacturing, and QC testing.

• Excellent communication skills (written, verbal, and presentation).

• Ability to thrive in a cross-functional, matrix environment with limited supervision.

• Strong project management and documentation skills.

Top 3 Must-Have Skills:

1. Previous experience as a change control and/or deviation owner/approver.

2. Strong project management skills.

3. Ability to work with limited supervision.

Compensation and Benefits:
This is a contract role with a pay rate of $45 - $47 per hour. Aditi Consulting offers competitive benefit options for eligible full-time employees, which may include medical, dental, and vision coverage, 401(k) participation, commuter benefits, 10 days paid leave, and life/disability insurance.