GMP Manufacturing Operator
at Medix

Date Posted: 8/23/2019

Job Description

** This position is located in Fargo, ND. Relocation Incentives will be provided!**

GMP BioManufacturing Operator I

Quality Statement

All employees are expected to be conscientious, self-motivated professionals, courteous to fellow staff members and clients, and to consistently perform their duties in a manner of the highest quality. Each individual working for the company has the responsibility for assuring the integrity and quality of the products and services the company provides.

Position Summary:

The BioManufacturing Operator will work daily within labs performing tasks associated with GMP services. The BioManufacturing Operator is expected to become familiar with all products and to be able to perform most tasks associated with the purification of plasmid DNA.

Essential Duties and Responsibilities:

  • Segregation, line clearance and cleaning of GMP production areas.

  • Planning and submitting inventory requisitions.

  • Planning and preparation for production events including preparing of processing plan memos.

  • Coordination for production events with buffer preparation operators.

  • Execution of GMP projects with either upstream or downstream tasks and all special considerations associated.

    • Upstream tasks including: Transformation, Subculture, Cell banking, Shake flask growth and harvest, Wave growth and harvest, Fermentation, Media fill events, Final formulation, filtration and dispensing.

    • Downstream tasks including: Project Set up, Lysis, Anion Exchange Chromatography, and Hydrophobic Interaction Chromatography (void and enrichment), Thiophilic Absorption Chromatography, Diafiltration, and small scale processing as well as linearization.

  • Completion of all documentation associated with GMP projects.

  • Coordination and sample submission with Quality Control.

  • Packaging of final material prior to shipment.

  • Equipment calibration and preventative maintenance.

  • Assisting in writing Manufacturing Summary Reports after project completion.

  • Maintain personnel training record.

  • Assist with assembly and segregation of all consumables and equipment resources for GMP production runs.

  • Participate and support of internal audit program by providing requested information and responding to findings presented in the audit report.

  • Communicate the status of operations, process issues, and safety and maintenance issues to appropriate area management.

  • Responsible for following SOP's and adhering to regulatory expectations.

  • Completion and maintenance of GMP Bill of Materials for GMP projects.

  • Completion of Metrics Tracking

  • All employees are responsible for the general upkeep of work and shared spaces.

  • Other duties as assigned.

Qualifications:

Experience:

  • 4 years of related experience or has established level of proficiency and demonstrated core competency

Education:

  • Bachelor's Degree in Life Sciences (Biology, Chemistry, Biotech) preferred

Skills and Knowledge:

  • Must possess excellent written and verbal communication skills

  • Apply basic math (arithmetic, ratios, proportions and conversions)

  • Good knowledge of computers and programs, like Microsoft Office and Smartsheet

  • Good organizational skills

  • Follow-through on methodology, understanding that bacteria are living organisms that do not adhere to a schedule.

Abilities:

  • Ability to work effectively within a team.

  • Ability to efficiently and accurately pipette into small vials.

  • Ability to shake, move, agitate, etc. glass vials and bottles.

  • Ability to lift and move material and equipment.

  • Ability to follow written procedures, and written and verbal directions.

  • Ability to keep records and maintain files.

  • Ability to self-report mistakes or concerns to their manager

Personal Characteristics:

  • Must be able to adhere to safety, health, and sanitation procedures

Working Conditions:

This position works in a segregated lab setting and may come in contact with various solutions and chemicals, and will be responsible for activities related to biological processes such as bacterial growth. This position uses standard laboratory equipment such as pipettes, centrifuges, glass ware, shake flasks, fermenters, fume hoods, and computers.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to see, talk and hear. The employee frequently is required to stand; walk; bend; lift up to 50 pounds; use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time. This position routinely works with large pieces of equipment.

Reference number: 23948

Job Snapshot

About Us

Medix provides workforce solutions to clients and creates opportunity for talent representing a variety of industries through our Healthcare, Scientific and Information Technology divisions. We have earned our reputation as an industry leader by providing unsurpassed customer service and top quality professionals to our clients.

At Medix we are extremely dedicated to our candidates, providing them with the best advice, support and direction during their job search. We work with all of our candidates personally to understand their skills and aspirations and best match them with opportunities that fit their goals. As we place contract, contract-to-hire and direct hire employment plans, we offer the flexibility to accommodate your schedule and needs.  We will also provide guidance and support during the interview process.  The benefits at Medix don’t stop there. After being employed for 30 days and averaging 30 hours per week for those 30 days, you become eligible for our benefit program.

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