Quality Control Analyst at Mallinckrodt Pharmaceuticals in Madison, Wisconsin

Posted in Other 12 days ago.





Job Description:

Job Title

Quality Control Analyst

Requisition

JR000011374 Quality Control Analyst (Open)

Location

ST-Madison - USA504

Additional Locations

Job Description

Summary

The Quality Control (QC) Analyst will work both independently and within a team to perform daily analysis of in-process samples, finished product and raw materials via established test methods while following cGMP and GDP in the QC laboratory. Typical analysis consists of pH, Osmolality, ELISA, PCR, Sterility, UV/Vis spectroscopy and other general chemical and bioanalytical assays.

Principal Responsibilities


  • Conducts routine analysis of in-process samples, finished products, and raw materials according to standard operating procedures (SOPs) and Master Specifications.

  • Utilizes proper aseptic technique during the execution of analysis.

  • Performs stability testing according to established schedules.

  • Documents and investigates any OOS results.

  • Follows cGMP and GDP to perform all tasks.

  • Documents and assesses data against established specifications.

  • Perform inventory, stock and clean QC laboratories.

  • Perform QC review of data records.

Department specific/Non-essential responsibilities:


  • Assist with calibrating and maintaining laboratory equipment.

  • May perform training of new and existing QC team on established methods and procedures

  • May provide technical expertise for method optimization, verification, qualification, and validation.

  • May develop and qualify testing methods and SOPs.

  • May assist with or lead QC projects for process improvements.

  • May draft reports, plans and protocols.

  • May revise and updates SOPs.

  • Additional duties as assigned.

Minimum Requirements

Experience / Skills:


  • Bachelor's degree in a scientific discipline or equivalent and a minimum of three years' related experience required.

  • Knowledge of cGMP is required.


  • Must possess skills and knowledge of general chemical and bioanalytical test methods.

  • Knowledge of ELISA, PCR, UV/Vis spectroscopy, cell culture and aseptic technique is preferred.

  • Experience with stability testing programs is preferred.

Competencies:

  • Attention to detail: able to organize and maintain data and information.

  • Ability to work in a controlled environment with gowning/PPE requirements.

  • Ability to learn through observation and hand's on experience.

  • Ability to work independently in a fast-paced, team oriented organization.

  • Strong written and verbal communication skills.

Organizational Relationship/Scope:


  • Reports to Quality Control leadership team.

  • Work is performed within a team of QC Analysts.

  • Regular communication with Quality, Manufacturing, Technical Operations among others.

Working Conditions:


  • 70% laboratory and manufacturing environment

  • 30% normal office and meeting room conditions

  • Must be able to perform work while aseptically gowned with the appropriate PPE

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