Quality Control Lead - 2nd Shift

Sharp Clinical Services, Inc.; Town of Bethlehem (NY); On-site; USD 60,000 - 80,000; Full time

Job summary

Sharp Packaging Services is seeking a detail-oriented Quality Control professional to perform inspections across components, in-process products, and finished goods. You will establish test standards, maintain reserve samples, and mentor QC staff on GDP and quality practices.

The role requires strong cGMP knowledge, documentation rigor, and the ability to work independently within a team. Join a global packaging provider committed to quality and regulatory excellence.

Qualifications

• High School Diploma or equivalent required; Bachelor’s degree preferred.
• 5+ years in pharmaceutical/biotech manufacturing/packaging or related QC/QA roles.
• Strong knowledge of cGMPs, FDA/DEA regulations, and CFRs.
• Proficient in documentation practices and data integrity.

Responsibilities

• Perform quality control inspections on components, in-process items, and finished products.
• Set in-process test standards and assure compliance to established standards.
• Inspect bulk drug and excipients; maintain reserve samples.
• Provide guidance on inspection techniques and GDP to QC staff.
• Perform physical testing using basic inspection instrumentation.
• Verify environmental conditions and change statuses per GMP.
• Ensure testing aligns with current procedures and sampling plans.
• Document work thoroughly and maintain detailed records.
• Maintain clean, safe work environment and adhere to safety standards.

Skills

Quality control

Attention to detail

Communication skills

Independent worker

Team collaboration

Education

High School Diploma or equivalent

Bachelor’s Degree preferred

Tools

Microsoft Office

Job description

ESSENTIAL DUTIES AND 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 established standards.
• Perform sampling and inspection of bulk drug and excipients.
• Set aside and maintain customer or Sharp Clinical Services reserve samples.
• Provide guidance to QC production team on inspection techniques, good documentation practices (GDP), and resolving any technical questions which may arise on shift.
• Perform physical testing using basic inspection instrumentation.
• Perform daily verification activities (temperature, humidity, weight on balances, etc.).
• Change 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 of cleaned GMP areas, equipment and utensils.
• Perform inspections thoroughly and with an exceptional level of detail in regard to quality.
• Excel in operating equipment.
• Identify and implement process changes that enhance efficiency and compliance of routine work.
• Author and revise SOPs and procedures.
• Provide thorough and effective training to QC trainees on cGMP, SOPs, BRs and quality events.
• Provide solutions or insight to other QC personnel regarding routine tasks.
• Ensure testing is in adherence to current procedures and sampling plans.
• Ensure compliance with cGMP and Sharp Clinical Services SOPs during clinical and commercial supply production.
• Ensure employees and visitors comply with applicable Sharp Clinical Services, Inc. SOPs.
• Assist in writing or executing change controls, CAPAs, investigations, technical problems, procedures, complaints and non-conformances which are approved in a timely manner.
• 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.
• Participate actively in routine meetings.
• Achieve expected performance measures.
• Communicate effectively and professionally.
• Demonstrate strong interpersonal skills, is approachable, engaged, presentable, and helps others.
• Perform other duties as assigned.

QUALIFICATIONS

• High School Diploma, Bachelors’ Degree or equivalent in related field preferred.
• Preferred 5 years 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.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to stand, use hands to finger, handle or feel, reach with hands and arms and talk or hear. Employee is occasionally required to walk and sit. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close, distance, ability to adjust focus, color and depth perception.

ENVIRONMENTAL CONDITIONS

While performing the duties of the job, the employee is occasionally exposed to fumes or airborne particles and is frequently working near moving mechanical parts. The employee is required to wear PPE such as a lab coat, safety glasses, and on occasion, an N-95 and PAPR (respirator). The noise level in the work environment is usually moderate.

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.