Quality Control Specialist

1 week ago

Allentown, Pennsylvania, United States Chipton-Ross Full time
Position Overview:

Chipton-Ross is seeking a Quality Assurance Inspector for a contract opportunity. This role is pivotal in ensuring the quality of clinical products throughout various stages including primary and secondary packaging, warehousing, and distribution.


Key Responsibilities:
  • Implement Good Manufacturing Practices (cGMP) across all responsibilities.
  • Uphold and promote the company's vision and values.
  • Conduct approvals of specifications and perform inspections on incoming materials and distribution shipments.
  • Carry out material and process inspections along with sampling activities.
  • Engage in continuous improvement initiatives and assist in root cause analysis for nonconformance issues.
  • Draft, revise, and adhere to all relevant Standard Operating Procedures (SOPs) and Work Instructions, ensuring proper documentation of activities.
  • Address 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.
  • Execute all tasks in a safe and efficient manner.
  • Perform additional duties as necessary to meet business needs.

Required Qualifications:
  • 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, and complaint management.
  • Strong reasoning and problem-solving abilities, along with basic math and 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:
  • Extensive standing and walking on the packaging floor to monitor activities.
  • Work schedule typically consists of Monday through Friday, 8 hours per day, with potential for overtime and weekend shifts.
  • Ability to stand, bend, and lift, with occasional lifting of up to 25 lbs and regular lifting of 10 lbs.
  • Exposure to cold temperatures for extended periods.
  • Compliance with visual acuity and color blindness standards for performing inspections in a cGMP environment.

Essential Requirements:
  • Ability to work in a refrigerated environment (35F to 46F) with provided protective gear.
  • Capability to operate in a freezer environment (-20F) with appropriate 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.

Education:

Accredited Associate's degree or an Accredited High School Diploma with 2 years of relevant experience.


Work Hours:

This is a full-time position, typically first shift from 6:45 AM to 2:45 PM, Monday through Friday, with overtime as needed.

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