Quality Control Technician IV - Micro

Mallinckrodt Pharmaceuticals Saint Louis , MO 63150

Posted 3 months ago

Job Title

Quality Control Technician IV - Micro

Requisition

JR000010274 Quality Control Technician IV - Micro (Open)

Location

St. Louis, MO (Pharma) - USA032

Additional Locations

St. Louis, MO

Job Description

SUMMARY OF POSITION:

Provide technical support at a specialist level. Provides solutions to a variety of technical problems of moderate scope while performing analysis on Finished Products, Raw Materials, Stability, water, and environmental monitoring samples. Requires minimal supervision.

ESSENTIAL FUNCTIONS:

  • Ability to conduct OOS Investigations providing root cause analysis and corrective action for Out of Specification Results

  • Perform product bioburden testing on incoming raw materials and finished products

  • Perform endotoxin testing by kinetic and gel clot methods

  • Performs water sampling at various production areas

  • Write and revise microbiology and other relevant SOP's as required

  • Takes an active role in laboratory QA functions including, but not limited to: OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, and auditing.

  • Participate in team meetings

  • Participate in cross-functional team to perform Root Cause Analysis for Laboratory Investigations

  • Rotate holidays and weekends as necessary to support a 24 hour production facility

  • Perform microorganism identifications using the Biolog Gen III system

  • Perform purified water testing as required by USP

  • Perform lab and plant environmental monitoring

  • Assist with establishing & maintaining safe work standards in the laboratory

  • Follow site HSE Policies

  • Peer review all levels of work

  • Perform method development for microbial limits testing per USP <61> & <62>

  • Order lab supplies including, but not limited to media, reagents, equipment

  • Follow good documentation practices for the accurate and timely documentation of all activities

  • Perform data release of all products and execute method development experiments

  • Demonstrate ability to troubleshoot most equipment and methods, assist in instrument calibration

  • Generate and review proposed changes to specifications (SMMs) through the change control system

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

  • LIMS entry, approval, and release of data

  • Takes a lead role in training/mentoring S2 & S3 in the group

  • Participates in determining objectives of assignments for group

  • Plans, schedules and arranges own and others activities in accomplishing objectives

  • Follows established procedures using own discretion and judgment as to the specific approach or technique

  • Serve as designee during Supervisor's absence

MINIMUM REQUIREMENTS:

  • Education: HS Diploma is required; Bachelor's degree in Biology, Microbiology, Life Science; or Associates degree with applicable experience in Biology, Microbiology, or Life Science is preferred.

  • Experience: 4-6 years of experience in a cGMP facility required. Wet chemistry, microbiological testing experience and advanced knowledge of industry principles, practices standards, theories and concepts is required. Typically assigned difficult, demanding or complex tasks, which may require independent action and a high degree of initiative. Good technical writing and oral communication skills. Computer literate with experience in MS Office. Seen as technical expert within the group.

  • Preferred Skills/Qualifications:
    Knowledge of environmental monitoring and instrumentation is a plus. Excellent technical writing and communication skills. Ability to mentor and train others and serve as leader of the group in supervisor's absence.

COMPETENCIES:

Informing, Customer Focus, Listening, Perseverance, Organizing, function/technical skills, Peer Relationships, Comfort around Higher Management

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

Reports to the Supervisor, Quality Microbiology. Contacts involve matters of moderate importance to the organization and include Quality Assurance, R&D, Marketing, Production Supervisors, Production Engineers, Production Lead Operators, Logistics, Safety, Regulatory, Training, Document Control and DEA. Infrequent customer contacts on routine matters.

WORKING CONDITIONS:
80% Laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds
20% Office environment

Required to work 8 hour shifts, the potential for night, weekend, and holiday work depending on the needs of the lab

DISCLAIMER:

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


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Quality Control Technician IV - Micro

Mallinckrodt Pharmaceuticals