QC Inspector - Production (2nd shift)

Sharp Clinical Services; Bethlehem (Northampton County); On-site; USD 42,000 - 54,000; Full time

Job summary

Sharp Clinical Services is seeking a Quality Control Inspector I to ensure compliance in cGMP programs, oversee documentation, and support operations and packaging processes. The role requires performing inspections, sampling, and verifying test results while maintaining detailed records and adhering to safety standards.

The ideal candidate has strong communication skills and the ability to work independently, with prior pharma/biotech experience preferred.

Qualifications

• High School Diploma or equivalent in related field preferred.
• 1 year of pharmaceutical or biotech manufacturing/packaging experience preferred.
• Excellent oral and written communication to interact with team and external contacts.
• Ability to interpret and apply cGMPs, FDA & DEA CFRs.

Responsibilities

• Perform quality control inspections on components, in-process items and finished products.
• Determine in-process test standards and ensure compliance with procedures.
• Sample and inspect bulk drug and excipients; maintain reserve samples.
• Verify drug product and components against approved manufacturing instructions.
• Maintain accurate, detailed records of work performed; communicate issues promptly.
• Adhere to safety standards and keep work environment clean and organized.

Skills

Oral and written communication

Independent work ability

cGMP/FDA/DEA regulation interpretation

Attention to detail

Education

High School Diploma or equivalent

Bachelor's degree or equivalent preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft 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.