QC Analyst 

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our pharmaceutical and healthcare client, whose purpose is to reimagine medicine to improve and extend people's lives. They use innovative science and technology to address some of society's most challenging healthcare issues. They discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.

Job Title: QC Analyst

Work Location: Wilson NC 27893

Job Type: Contract

Duration: 3 Months

Work Type: On Site

Job Description:

• Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time.

• Knowledgeable in the use of production related IT systems such as SAP and MES

• Documents all steps in the assigned Batch record in line with GMP requirements

• Responsible for successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.

• Maintains an "audit ready" module

• Perform other duties as assigned; ie. batch record review, process streamline improvements, safety walk-thrus

• Media preparation adheres to the production schedule to ensure adequate approved media inventories.

• ISO 8 Activities

• Ensure accurate SAP inventories are maintained for all components.

• Proper status segregation and storage of media lots.

• Support the maintenance of an "audit ready" state of the ISO 8 Area

• Timely response to all module requests.

• Batch Records are properly kitted and staged based on production schedule.

• All gowning materials in the ISO 8 area are maintained to adequate levels.

• ISO 8 area has ample supply of non-inventory items

Key Performance Indicators

• Right First Time Batch Record execution

• MBR right first time

• Cycle Count Inventories are accurate

• 98% training compliance

• No major or critical audit findings pertinent to the ISO 8 area and media production

Skills

Experience:

• Experience in aseptic manufacturing preferred

• Knowledge of cGMP regulations and FDA guidance preferred
  
  

Other preferred Qualifications:

• Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required.

• Must be well organized, flexible and work with minimal supervision.

• Ability to lift up to 35 lbs.

• Alternate shifts, weekends and overtime will be required

• Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials
  

Values & Behaviors:

• Ability to adapt and learn new systems

• Ability to collaborate with other groups, teams and departments in addressing inventory related issues.

• Speak Up Mentality.

• Demonstrate a high level of discipline and self-motivation.

• Maintains composure during stressful situations.

• Provides innovative solutions to complex or process improvement issues.
  

Education

• Associate degree in in Biology or scientific discipline. If no degree, a minimum of 1-3 years experience in cGMP/FDA regulated industry.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.