Quality Control Lead - 2nd Shift

The Quality Control Lead, Production ensures compliance in company programs to maintain adherence to procedures, processes, and cGMP standards. The QC Lead provides cGMP oversight, process leadership, and quality‑related guidance on the production floor regarding documentation, inspection, and manufacturing/packaging processes.

Responsibilities

• Perform quality control functions including component, in‑process, and finished product inspections according to established procedures.
• Determine proper in‑process test standards and assure compliance to established standards.
• Sample and inspect bulk drug and excipients; set aside and maintain customer or Sharp Clinical Services reserve samples.
• Guide the QC production team on inspection techniques, good documentation practices (GDP), and resolve technical questions that arise on shift.
• Conduct physical testing using basic inspection instrumentation and daily verification activities (temperature, humidity, balance weights, etc.).
• Change status of material, GMP areas, equipment, and utensils; determine if in‑process test results are within specifications.
• Suspend operations and notify supervisor of any out‑of‑specification results.
• Perform pre‑production line clearance of GMP areas prior to production start.
• Verify drug product and components against approved Manufacturing Instructions before production.
• Verify cleaned GMP areas, equipment, and utensils.
• Execute inspections with exceptional detail and operate equipment proficiently.
• Identify and implement process changes that enhance efficiency and compliance.
• Author and revise SOPs and procedures.
• Provide thorough training to QC trainees on cGMP, SOPs, BRs, and quality events.
• Offer solutions or insight to other QC personnel regarding routine tasks.
• Ensure testing adheres to current procedures and sampling plans.
• Maintain 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 in a timely manner.
• Maintain accurate, detailed records of work performed and communicate quality or cGMP issues promptly to supervisor.
• Collaborate with internal staff to meet scheduled requirements.
• Maintain a clean, orderly, and safe work environment and adhere to safety standards.
• Participate actively in routine meetings, achieve performance measures, and communicate effectively and professionally.
• Demonstrate strong interpersonal skills, approachability, engagement, and willingness to help others.
• Perform other duties as assigned.

Qualifications

• High School Diploma; Bachelor’s Degree or equivalent in a related field preferred.
• Approximately 5 years of experience in pharmaceutical or biotech manufacturing/packaging, preferably in Quality Control, Quality Assurance, Manufacturing, or Compliance.
• Ability to work independently, manage multiple tasks simultaneously, and meet critical timelines.
• Excellent oral and written communication skills for interaction with team members, peers, management, and external contacts.
• Capability to interpret and implement cGMPs, FDA & DEA regulations, and CFRs.
• Strong working knowledge of personal computers and Microsoft Office (Word, Project, Excel).

Physical Demands

The employee is frequently required to stand, use hands to finger, handle or feel, reach with hands and arms, and talk or hear. Occasionally required to walk and sit. Must occasionally lift and/or move up to 30 pounds. Vision requirements include close, distance, focus adjustment, color, and depth perception.

Environmental Conditions

The role may involve occasional exposure to fumes or airborne particles and frequent work near moving mechanical parts. Personal protective equipment includes a lab coat, safety glasses, and, as needed, an N‑95 respirator or PAPR. Noise level is usually moderate.