Quality Control Analyst at Mallinckrodt Pharmaceuticals in Madison, Wisconsin

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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