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Quality Operations Visual Inspector - Tier I

NEPHRON SC, LLCWest Columbia, SC
Onsite

About The Position

The Quality Operations Visual Inspector - Tier I is responsible for performing visual inspections of injectable products in compliance with company policies, FDA, and cGMP regulations. This role involves maintaining quality assurance documentation, ensuring the accuracy and completeness of batch records, and promoting teamwork within the QA team and with other departments. The inspector will monitor packaging areas and personnel for adherence to cGMP, SOPs, and safety regulations, and keep the work station clean and orderly. Key duties include performing line clearance, verifying equipment, components, and labels, and communicating quality-related observations and issues to the Supervisor. The position requires specific expertise in quality assurance, the ability to adapt to changing demands, manage diverse projects, and foster a positive team environment. Incumbents must also effectively manage themselves, demonstrate integrity, be productive under pressure, and achieve development goals. They are required to wear hearing protection and other protective equipment as necessary.

Requirements

  • Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred.
  • Knowledge of GMP preferred.
  • Good written, oral and comprehensive communication skills.
  • Strong understanding of document control procedures, standards, and best practices.
  • Detail oriented.
  • Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills.
  • Good visual acuity and observation skills.
  • Able to handle diversity of projects.
  • Specific expertise, skills and knowledge within quality assurance gained through education and experience.
  • A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
  • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  • The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
  • The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
  • Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary.
  • Visual Inspection certification
  • 1-3 years of related experience in the pharmaceutical industry.
  • High School Diploma or GED

Nice To Haves

  • Knowledge of GMP preferred.

Responsibilities

  • Perform visual inspection of injectable products in compliance with company policies/procedures, FDA and cGMP regulations.
  • Maintain quality assurance documentation by ensuring the accuracy and completeness of batch records.
  • Promote teamwork both within the QA Team and other departments.
  • Monitor all packaging areas and personnel for adherence to all cGMP, SOP's and safety regulations.
  • Keep line and work station clean and orderly.
  • Perform line clearance including equipment, components and label verification.
  • Communicate quality-related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor.
  • Monitor and perform finished product attribute inspections.
  • Perform visual inspections of Outsourcing products if deemed necessary or required.
  • Support secondary packaging operations by performing QA verifications of packaging, label verifications, etc.
  • Maintain quality documentation and review to ensure completion and compliance.
  • Ensure that there is no cross contamination.
  • Perform line clearances.
  • Support validation and manufacturing studies including special sampling and testing.
  • Organize workload during lot changeovers for efficient execution.
  • Assist with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.
  • Assist with development of solutions for chronic problems within quality assurance.
  • Communicate quality-related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.
  • Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.
  • Assist in other activities (as needed) for Quality Assurance management.
  • Copying, filing, and scanning of documents.
  • Perform other similar duties as required.

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