QC Inspector - Production (2nd shift)

Sharp Services, LLC; Bethlehem, Northern (Northampton County, KY); Hybrid; USD 48,000 - 68,000; Full time

Job summary

Sharp Packaging Services seeks a Quality Control Inspector I to ensure compliance in its programs and oversee cGMP adherence for documentation, inspection, and manufacturing/packaging processes. The role involves performing inspections, sampling, and verifications across GMP areas and communicating any deviations promptly.

Ideal candidates possess a high school diploma or higher, pharmaceutical experience, and strong communication skills to coordinate with Operations and Logistics.

Qualifications

• Excellent verbal and written communication required.
• Ability to interpret and implement cGMPs, FDA & DEA regulations.
• Ability to work independently, handle multiple tasks and meet timelines.
• Strong attention to detail and adherence to quality standards.

Responsibilities

• Perform quality control functions including component, in-process and finished product inspections.
• Determine proper in-process test standards and ensure compliance.
• Perform sampling and inspection of bulk drug and excipients.
• Maintain accurate, detailed records of work performed and communicate issues to supervisor.
• Verify drug product and components against Manufacturing Instructions prior to production initiation.
• Ensure testing adheres to current procedures and sampling plans; maintain cGMP compliance.

Skills

Communication skills

Education

High School Diploma or equivalent

Bachelor's degree in related field

Tools

Microsoft Office (Word, Excel, Project)

Job description

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

Essential Duties and Responsibilities include the following.

• 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.

Other duties may be assigned.

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.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry.

We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands.

We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products.

Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery.

Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.