Manufacturing Tech IV
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POST DATE 8/27/2016
END DATE 11/8/2016
Round Rock, TX
JOB DESCRIPTION**This is an Evening Shift Monday - Friday 1:00PM -10:00PM**
The Formulation Technician is responsible for the preparation of reference standard solutions and raw/neat material aliquots, calibration curves and check standards to support catalog, customer-specific products, and Certification and Stability programs for MilliporeSigma raw materials and finished products. The Formulation Technician will execute and complete the preparation of reference standard solutions and neat material aliquots as designed and documented to produce finished products and to meet production goals. The Formulation Technician will initiate forms or batch records as needed for projects, and review all batch records and forms to ensure completeness and correctness of all information prior to execution.
The Formulation Technician will ensure on-time project completion, communicate any delays, and make sure that the work is performed per the requirements of the customer, in compliance with MilliporeSigma Quality and Safety policies and good housekeeping practices.
ESSENTIAL JOB FUNCTIONS
· Prepare reference standard solutions, calibration curves and neat material aliquots. Complete all projects as designed and documented to produce finished products and meet production goals.
· Support Certification and Stability programs for MilliporeSigma raw materials and finished products through raw material sampling and check standard preparation.
· Review all batch records and forms to ensure correctness of all information prior to project execution. Identify errors and initiate specification change forms to adjust for any necessary corrections.
· Prepare batch records and revise forms based on scheduling to support catalog remakes, new products, CIL and customer specific reference standards.
· Assume and move projects through the product management system (PMS) to the appropriate department upon initiation and completion.
· Identify, organize and facilitate accessibility of supplies for upcoming projects.
· Update the manager and/or Team Lead on project status and on any issues and concerns, or when production targets cannot be achieved.
GENERAL JOB FUNCTIONS
· Prepare reference standard solutions, neat material aliquots and/or labeling and packaging operations to support catalog production and custom orders.
· Perform specified manufacturing processes as designed and documented to produce finished products to meet production goals.
· Serve as a Project Lead and/or point-of- contact for specific projects as assigned by the lab manager to:
o Coordinate project-specific meetings to communicate project details to team members so that the group understands requirements and deadlines.
o Ensure that the work is executed correctly, in compliance with customer requirements, MilliporeSigma Quality and Safety policies, good housekeeping practices, and performed in a timely manner.
· Ensure that the Laboratory is maintained in a state of "audit readiness" that includes a clean and organized work environment. The lab should be free of clutter, trash, chemicals and materials that are not in use.
· Perform all tasks in accordance with MilliporeSigma policies, procedures, and cGMP requirements as applicable and demonstrate capabilities through current training records. All aspects of training records are required to be current.
· Maintain the group laboratories in a state that adheres to hazardous waste management practices incorporating local, state and federal regulations and training. Responsibilities include understanding and applying waste management minimization procedures, consulting with the Waste Specialist (VP of RA) and lab manager to ensure that proper procedures are in place for dealing with any new or unfamiliar waste materials.
· Communicate with manager and/or Team Lead any issues and concerns and when production targets cannot be achieved.
· Understand and review all calculations used for production processes.
· Review project design to ensure that all regulatory requirements are known and met for each
· Verify that the due dates of all calibrated and qualified equipment are effective prior to use, and help to ensure that all calibration requirements are met as scheduled.
· Maintain an inventory of parts and supplies needed to keep operations and equipment running with minimal disruption in productivity.
· Evaluate production processes to determine innovative alternatives.
· Review operations and develop suggestions and ideas for continuous improvement of processes and procedures.
· Write batch records and forms to support catalog and/or custom production and function as a reviewer of such documentation. Assist in direct training and/or mentoring of staff through the proficiency testing program and project-specific related requirements.
· Perform regular production and support activities of other areas or other duties as assigned by the manager.
· Be prepared to work alternate shifts as designated by the lab manager.
· Attend all group meetings as scheduled.
BS degree in an applicable science field with up to 5 years of experience or an Associate Degree in an applicable science field with 5+ years of experience.
Knowledge and Skills:
The Formulation Technician has a basic working understanding of MilliporeSigma and customer products, their applications and requirements. The Formulation Technician has an understanding of MilliporeSigma quality system requirements for GMPs, GLPs, ISO and other regulations; of departmental goals, interdepartmental and MilliporeSigma processes, and overall goals. He/she is detail oriented, and pays attention to small details. The Formulation Technician has good verbal, written, problem-solving and computer skills. He/she must be able to write technical documents such as batch records, procedures, and reports.
MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.