QC Inspector - Production (2nd shift)

Being part of the team at Sharp means being a dependable partner who always comes through on time and as promised. We go the extra mile for our customers and their patients — and for each other - building long-lasting, trusting relationships.

About Sharpservices (Sharp)

If you want to join this kind of team, read on.

Responsibilities

• The Quality Control Inspector I ensures Company compliance in its programs to prevent or eliminate deviations in procedures and adherence to cGMP standards.
• Providing cGMP oversight and guidance to Operations and Logistics departments regarding quality related to documentation, inspection, and manufacturing/packaging processes.
• Duties and Responsibilities include the following.
• Other duties may be assigned. ▪ 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.

Requirements

• 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.