Demo

Quality Assurance Specialist

Caligor Coghlan
Bastrop, LA Full Time
POSTED ON 2/27/2025
AVAILABLE BEFORE 5/24/2025

Company Description :

Caligor Coghlan (CalCog) is a vertically integrated clinical supply services company that provides sourcing, packaging, labeling, storage, and distribution services for early to late phase global clinical trials. We pride ourselves in making it our business to find a better way to deliver for our clients and the patients they serve. Our dedicated people care - about their work, their team, and the results we strive to deliver every day.

If you are looking for a role that supports the types of endeavors listed above in the world of drug supply services, where what you do and how you do it will make a difference, then this position is for you.

Job Summary :

The Quality Assurance (QA) Specialist, Level III, will be responsible for the daily execution of tasks associated with internal / external audit and non-conformance administration (Incident / Deviation / Complaint / CAPA). Additionally, this position will be responsible in assisting of receiving / inspection / release of labels, receiving / inspection / release of clinical trial materials and its ancillary supplies, review of batch records, review of distribution material review of maintenance logs, and other functions and / or cross-functional tasks essential to the daily operations of the Quality Assurance department.

Key Responsibilities :

  • Working with the QA Director to maintain and improve the daily QA operations.
  • Ensures compliance to GxP and SOPs for assigned tasks and responsibilities.
  • Identifies operational quality problems, issues, obstacles, and barriers across production and shipping related activities and communicates observations, patterns and trends to QA Director, as appropriate; participates in and supports efforts to develop and implement quality process improvements.
  • Provides and / or organizes Quality system training for new and existing personnel to improve compliance. Supports the development and presentation of quality systems training material.
  • Leads and assists in the preparation, coordination, and execution of internal / external audits.
  • Maintains and monitors quality metrics. Compiles Monthly / Quarterly / Annual quality metrics reports. Assists in the preparation of Quality metrics for Management Review meetings.
  • Assists in the communication with prospective vendors, qualification of new vendors, and re-qualification of previously qualified vendors.
  • Provides assistance in reviewing / releasing Receiving records, Distribution records, Pre-production / Post-production Batch Records (as needed).
  • Provides assistance in reviewing / releasing of labels for production, including review of label text per client approved label proof and randomization files.
  • Provides in-process QA inspections for all outbound shipments (as needed).
  • Assists management with planning and facilitating Regulatory or client audits.
  • Assists with the organizing, planning, and drafting of audit responses.
  • Works directly with clients and project management as needed to provide Quality solutions and feedback.
  • Leads Quality projects as assigned by QA Director.
  • Provides mentorship to junior level Quality team members.
  • Other duties or tasks as assigned by QA Director.

Competencies, Traits and Skills :

  • Must have expert level knowledge of QMS functions, including but not limited to : CAPA, change control, complaint, deviation, investigation, root cause analysis and good documentation practices.
  • Strong organizational skills with multitasking capabilities.
  • Ability to interpret and apply GxP and company SOP knowledge at all times.
  • Strong interpersonal skills and the ability to manage, motivate, influence and conduct quality work behaviors in self and others.
  • Flexible, enthusiastic and highly motivated to work in a challenging environment.
  • Proficient knowledge of various computer applications to include Microsoft Office applications.
  • Attention to detail and statistical aptitude.
  • Position entails a high level of independence, initiative and requires an aptitude for attention to details, investigation, analysis, and problem solving. Works mostly within set guidelines to achieve project goals. It is necessary to use specific and established procedures and creative initiative to accomplish tasks.
  • Requires the ability to apply professional level knowledge and skills with applicable regulations and company SOPs to ensure proper control of labels, labeling materials, packaging materials and randomization or treatment group assignments.
  • Must be able to organize and plan workload to support all CalCog projects to meet deadlines.
  • Confidence required ensuring proper communications between project team members and client to ensure the timely delivery of project information, production records, and randomization audit reports.
  • Must have excellent verbal skills to effectively communicate to client and project team members. Able to initiate discussions with client Quality Assurance representatives or project team to anticipate special Quality Assurance requirements.
  • Qualifications :

  • Bachelor’s Degree.
  • 3 years working with QMS functions, including but not limited to : CAPA, change control, complaint, deviation, investigation, root cause analysis and good documentation practices.
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    Job openings at Caligor Coghlan

    Caligor Coghlan
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    Company Description : Caligor Coghlan (CalCog) is a vertically integrated clinical supply services company that provides...
    Caligor Coghlan
    Hired Organization Address Bastrop, TX Full Time
    Company Description: Caligor Coghlan (CalCog) is a vertically integrated clinical supply services company that provides ...

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