Quality Control Inspector

1 week ago

Allentown, Pennsylvania, United States Mindlance Full time

Work Schedule:
Second shift, 3:15 PM - 11:15 PM, Monday to Friday. Overtime as required.

Position Overview:

Mindlance is seeking a Quality Control Inspector who will ensure the integrity of clinical products throughout the packaging, warehousing, and distribution processes.

This position demands meticulous attention to detail, the ability to identify defects and discrepancies, and effective communication skills, both verbal and written. Collaboration with various teams to resolve issues is essential.


Qualifications:
Education:
  • Associate's degree or High School Diploma with a minimum of 2 years of relevant experience.

Key Responsibilities:
  • Implement Good Manufacturing Practices (cGMP) in all assigned tasks.
  • Uphold and promote the company's vision and values.
  • Conduct approval of specifications and perform incoming inspections on materials and distribution shipments.
  • Execute material and process inspections and sampling procedures.
  • Engage in continuous improvement initiatives and assist in root cause analysis for nonconformance issues.
  • Draft, revise, and adhere to all pertinent Standard Operating Procedures (SOPs) and Work Instructions, documenting activities as necessary.
  • Identify and escalate any issues that may impact product quality or compliance to the Team Leader or Management.
  • Ensure timely resolution of issues and implementation of corrective actions.
  • Conduct all activities safely and efficiently.
  • Additional duties may be assigned to meet operational needs.

Knowledge, Skills, and Abilities:
  • At least 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.
  • Ability to work in a refrigerated environment (35°F to 46°F) with appropriate protective gear.
  • Capability to operate in a freezer environment (-20°F) with provided protective wear.
  • Experience working in potent compound suites with necessary personal protective equipment (PPE).
  • Strong reasoning and problem-solving abilities, basic math skills, and good communication capabilities.
  • Willingness to work various shifts and overtime based on business requirements.
  • Ability to work independently.
  • Proficient in understanding and adhering to SOPs and policies within a GMP environment.

Physical Requirements:
  • No allergies to penicillin or cephalosporin products.
  • Ability to stand and walk extensively on the packaging floor to monitor activities.
  • Work schedule consists of Monday through Friday, 8 hours per day, with potential for overtime and weekend shifts.
  • 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.
  • Exposure to -20°F temperatures for brief intervals.
  • Work may involve atmospheric conditions requiring special personal protective equipment.
  • Must meet visual acuity and color blindness standards for performing inspections in a cGMP environment.

Equal Employment Opportunity:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment based on minority status, gender, disability, religion, sexual orientation, age, or veteran status.

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