Day to Day Responsibilities:

• Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
• Performs review and approval of cGMP processes, procedures, documents and records.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Review executed batch records, attachments, and area logbooks.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alert senior management of quality, compliance, supply and safety risks.
• Complete required assigned training to permit execution of required tasks.

Requirements:

• Academic background in Sciences, and experience working in Quality Assurance in either Biotech or Pharmaceutical industry.
• In alignment with what we have defined for FTE Sr. Associate QA role - Master's degree OR Bachelor's degree and 2 years of experience (in QA or MFG) OR Associate's degree and 6 years of experience (in QA or MFG).

Top 3 Must Have Skill Sets:

• Industry experience in BioTech or Pharmaceuticals.
• Quality or Manufacturing experience.
• Academic background in Sciences.

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 a number of factors, including but not limited to, a candidate's qualifications, skills, 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.