Quality Control Inspector
2 weeks ago
Working Hours:
Second shift, 3:15 PM - 11:15 PM, Monday to Friday. Overtime as required.
Role Overview:
Mindlance is seeking a dedicated Quality Control Inspector tasked with ensuring the integrity of clinical products throughout the primary and secondary packaging, warehousing, and distribution processes.
This position demands meticulous attention to detail, the ability to identify defects and discrepancies, effective verbal and written communication skills, and collaboration with various teams to resolve issues.
Qualifications:- Educational background: Associate's degree or High School Diploma with a minimum of 2 years of relevant experience.
- Implement Good Manufacturing Practices (cGMP) across all responsibilities.
- Promote and embody the company's vision.
- Conduct approval of specifications and incoming inspections for materials (e.g., drugs, components) and distribution shipments.
- Execute material and process inspections and sampling.
- Engage in continuous improvement initiatives and assist in root cause analysis for nonconformities.
- Draft, revise, and adhere to all pertinent Standard Operating Procedures (SOPs) and Work Instructions, ensuring accurate documentation of activities.
- Identify and escalate issues that may impact product quality or compliance to the Team Leader and/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 to fulfill business requirements.
- At least 1 year of experience in the pharmaceutical or a related regulated industry, along with a high school diploma.
- Familiarity with Quality Systems (Change Control, deviations, complaint management, documentation management, etc.).
- Ability to work in a refrigerated environment (35°F to 46°F) with appropriate protective gear.
- Capability to operate in a freezer (-20°F) environment with necessary protective equipment.
- Experience working in potent compound suites with provided personal protective equipment (PPE).
- Strong reasoning and problem-solving abilities, basic math skills, effective communication skills, and fundamental computer skills.
- Willingness to work various shifts and overtime as needed.
- Ability to work independently.
- Proficiency in understanding and adhering to SOPs and policies within a GMP environment.
- No allergies to penicillin or cephalosporin products.
- Ability to stand and walk extensively on the packaging floor to monitor activities.
- Standard work schedule: Monday through Friday, 8 hours per day, with potential for additional overtime and weekend work.
- Physical demands include 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 conditions may require special personal protective equipment.
- Must meet visual acuity/color blindness standards for performing visual inspections in a cGMP setting.
Equal Employment Opportunity:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment based on minority status, gender, disability, religion, LGBTQI, age, or veteran status.
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