QC Inspector - Production (2nd shift)

About the role

The Quality Control Inspector I ensures Company compliance in its programs to prevent or eliminate deviations in procedures and adherence to cGMP standards. Provides cGMP oversight and guidance to Operations and Logistics departments regarding quality related to documentation, inspection, and manufacturing/packaging processes.

Responsibilities

• Perform quality control functions including but not limited to component inspections, in-process inspections and finished product inspections according to established procedures.
• Determine proper in-process test standards and assure compliance to same.
• Perform sampling and inspection of bulk drug and excipients.
• Pull and maintain customer/Sharp Clinical Services reserve samples.
• Perform physical testing using basic inspection instrumentation.
• Perform daily verification activities (temperature, humidity, weight on balances, etc.).
• Change the status of material, GMP areas, equipment, and utensils.
• Determine if in-process test results are within established specifications. Responsible for suspending operations and notifying supervisor of any out of specification results.
• Perform pre-production line clearance to the GMP Area prior to the initiation of production.
• Perform verification of drug product and components against approved Manufacturing Instructions prior to the initiation of production.
• Perform verification on cleaned GMP Areas, equipment and utensils.
• Ensure testing is in adherence to current procedures and sampling plans.
• Ensure compliance with cGMPs and Sharp Clinical Services SOPs during clinical and commercial supply production.
• Maintain accurate, detailed records of work performed.
• Provide timely communication of quality or cGMP issues to supervisor.
• Work with internal staff to meet scheduled requirements in a timely manner.
• Remain accountable for maintaining a clean, orderly, and safe work environment.
• Adhere to set safety standards.

Qualifications

• High School Diploma, Bachelors' Degree or equivalent in related field preferred.
• Preferred 1 year of prior experience in pharmaceutical or biotech manufacturing/packaging (a Quality Control, Quality Assurance, Manufacturing or Compliance role is preferred).
• Ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
• Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
• Ability to interpret and implement cGMPs, FDA & DEA Regulations and CFRs.
• Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.