LSNE Contract Manufacturing

JOB SUMMARY -

This position provides QA support in the manufacturing of clinical and commercial drug products/medical devices to ensure compliance with the principles and guidelines of cGMP. QA Associates maintain the quality systems, such as laboratory control, investigation management, materials management, document control and training to ensure control of the manufacturing process. This position will actively partner with Manufacturing Operations, Facilities, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner.

JOB DUTIES -

  • Provide support to all cGMP manufacturing operations in real time on the floor and oversee production activities and monitors dP/NVP as applicable:
    • Responsible for performing routine manufacturing area line clearances
    • Participate in Investigations into Facility, EM, and Utility excursions as assigned
    • Assist with product / material labeling and disposition functions
    • Complete AQL Sampling and Inspection of Final Package Lots as applicable
    • Review OJT training for gowning, facility flow and visual inspection
    • Review of executed Raw material, protocol and manufacturing records under direct supervision    
    • Review Manufacturing and Quality logbooks
    • Responsible for writing and revising Standard Operating Procedures, material control procedures, deviations, CAPA's, and Quality Investigations when applicable under direct supervision
  • Track and Maintain Calibration Certificates, generate monthly calibration certification reports, and quarterly Preventative Maintenance reports
  • QA review of QASR's(QC data summary reports)  
  • Direct involvement in supporting external client audits and regulatory inspections
  • For positions at aseptic manufacturing facilities, gowning qualification is a must for line clears
  • Assist in routine filing of Quality records
  • Maintain and update all production records and evaluate all procedures and monitor all new regulations

EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE -

  • High school diploma with 5+ year's relevant GMP experience; Bachelor's degree in a science or related discipline with 0-2 year's relevant experience
  • Experience executing GMP quality systems in a pharmaceutical/biotech/medical device environment preferred
  • Experience supporting manufacturing and conducting training is preferred
  • Knowledge of FDA/ISO regulatory requirements as well as industry trends
  • Computer knowledge, including Microsoft Office, Windows
  • Excellent interpersonal skills and the ability to communicate well orally and in writing
  • Ability to multi-task in a dynamic environment with changing priorities

PHYSICAL REQUIREMENTS -

    • Ability to gown and work in an ISO-5 environment preferred
    • Must be able to work while wearing PPE for all GMP areas for an entire shift (includes non-latex gloves, hair/beard covers and lab coats)
    • Requires the ability to lift, carry, push or pull light weights (up to 20 pounds)
    • Requires bending, squatting, climbing and reaching
    • Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English
    • Requires the ability to communicate effectively using speech, vision, hearing and written word
    • Must be able to sit or stand for long periods of time

COMMUNICATIONS & CONTACTS - Interacts with all departmental staff

MANAGERIAL & SUPERVISORY RESPONSIBILITIES Not Applicable

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

*LSNE offers competitive compensation and benefits packages and a very generous paid time off package*

LSNE Contract Manufacturing
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