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Quality Control Specialist

2 months ago

Allentown, Pennsylvania, United States Chipton-Ross Full time
POSITION SUMMARY:

Chipton-Ross is seeking a Quality Assurance Inspector who will be responsible for ensuring the quality of clinical products throughout various stages including primary and secondary packaging, warehousing, and distribution operations.

This position demands a meticulous eye for detail, the ability to identify defects and discrepancies, and effective communication skills, both verbal and written. Collaboration with cross-functional teams for problem resolution is essential.


KEY RESPONSIBILITIES:
  • Implement Good Manufacturing Practices (cGMP) in all areas of responsibility.
  • Promote and embody the company's vision.
  • Conduct approval of specifications and incoming inspections on materials and distribution shipments.
  • Perform inspections and sampling of materials and processes.
  • Engage in continuous improvement initiatives and assist in root cause analysis for nonconformities.
  • Draft, revise, and adhere to all relevant Standard Operating Procedures (SOPs) and Work Instructions, ensuring proper documentation of activities.
  • Identify and escalate issues that may impact product quality or compliance to the Team Leader or Management.
  • Ensure timely resolution of issues and implementation of corrective actions.
  • Carry out all tasks in a safe and efficient manner.
  • Additional duties may be assigned as needed to support business operations.

EXPERIENCE REQUIREMENTS:

Minimum of 1 year of experience in the pharmaceutical industry or a related regulated field, along with a high school diploma.

  • Familiarity with Quality Systems, including Change Control, deviations, complaint management, and documentation management.
  • Strong reasoning and problem-solving abilities, basic math skills, and effective communication skills.
  • Proficient in understanding and adhering to SOPs and policies within a GMP environment.
  • Must not have allergies to penicillin or cephalosporin products.

PHYSICAL REQUIREMENTS:
  • Ability to stand and walk extensively on the packaging floor to monitor activities.
  • Work schedule is Monday through Friday, 8 hours per day, with potential for overtime and weekend work.
  • Position requires standing, bending, and lifting, with the ability to lift up to 25 lbs occasionally and 10 lbs regularly.
  • Exposure to cold temperatures for extended periods, including -20F for brief intervals.
  • Compliance with visual acuity and color blindness standards for performing visual inspections in a cGMP setting.

HARD REQUIREMENTS:
  • Capability to work in a refrigerated environment (35F to 46F) with appropriate protective gear.
  • Ability to work in a freezer (-20F) environment with provided protective wear.
  • Willingness to work in potent compound suites with necessary personal protective equipment (PPE).
  • Flexibility to work various shifts and overtime as required by business needs.
  • Ability to work independently.

EDUCATIONAL REQUIREMENTS:

Accredited Associate's degree or a high school diploma with a minimum of 2 years of relevant experience.


WORK HOURS:

Full-Time; First Shift 6:45 AM - 2:45 PM, Monday-Friday. Overtime as needed.