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Grifols Shared Services North America, Inc Oligo Synthesis Chemist II in San Diego, California

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Summary:

Responsible for the manufacture of oligonucleotides to be used in bulk clinical and commercial kit reagents. Responsible for synthesis, purification, diafiltration and labeling of oligonucleotides, raw material preparation and/or processing, and in-process testing. May be assigned to one or more functional Manufacturing areas. Identify, recommend and participate in nonconformance investigations and continuous improvement projects. Participate in new process transfers.

Primary responsibilities for role:

  • Follow all safety rules

  • Responsible for handling of raw material inventory and synthesis and labeling of oligonucleotides

  • Responsible for identifying and communicating production issues, safety incidences and/or personal issues affecting availability

  • Maintains, measures and dispenses materials

  • Performs material and labor transactions in the Enterprise Resource Planning (ERP) System

  • Understands and executes written procedures in accordance with Current Good Manufacturing Practices (cGMP)

  • Maintains detailed and accurate device history records and log books using Good Documentation Practices (GDP)

  • Completes and forwards device history records for review in a timely manner

  • General manufacturing area housekeeping including cleaning of labware, equipment, shelves, benches and sinks and removing trash

  • Ensures proper transportation, handling, and disposal of hazardous, bio-hazardous and/or infectious substances.

  • Perform and maintain general equipment maintenance, operation and calibration

  • Maintains accurate and complete training records

  • Prepares for audits, including ISO, FDA and internal audits

  • Train Oligo Synthesis Chemist I

  • Responsible for cycle counts to verify inventory accuracy and coordinate with Manufacturing Supervisor/Lead to disposition expired material

  • Aid metrology liaison to ensure on-time calibration of production equipment

  • Participate in process improvement projects from inception to completion

  • Initiate and participate/support in nonconformance investigations

  • Participate in manufacturing activities associated with new process transfers

  • Recommends improvements and revisions to device master records & Standard Operating Procedures (SOPs)

Additional Responsibilities:

  • May cross-train in all areas of manufacturing and operations

  • Receives and verifies the accuracy of materials transferred from the Warehouse

  • Assist in maintaining compressed gas cylinders, and chemical tanks and distribution systems

  • May be responsible for flushing water ports and eyewash stations

  • Performs refrigerator/freezer maintenance

  • Assists Bulk Formulation Operations as needed

Knowledge, Skills, and Abilities:

  • Is fully trained and competent on the operation of simple laboratory equipment and processes.

  • Working knowledge of laboratory science, procedures, techniques, instruments & equipment

  • Working knowledge of general laboratory safety and record keeping

  • Working knowledge in the operation of analytical balances, pipettes, filter integrity testers, rotovap, centrifuges, water baths and spectrophotometers

  • Intermediate knowledge in the set-up and operation of Akta Oligopilot Synthesizers, Aktapilot/Beckman, Dionex/Vanquish or equivalent chromatography systems

  • Basic knowledge of troubleshooting Akta Oligopilot Synthesizers, Aktapilot/Beckman, Dionex/Vanquish or equivalent chromatography systems

  • Basic knowledge of Unicorn/Chromeleon software is required

  • Basic knowledge of ERP systems

  • Ability to follow oral and written instructions

  • Working knowledge of Microsoft Office software

  • Must be able to multi-task to adhere to target manufacturing deadlines

  • Good organizational skills

  • Attention to detail

  • Team-oriented

  • Punctuality and attendance

  • Attentiveness and openness to learn new processes

  • Ability to effectively communicate with cross-functional partners (e.g., Supply Chain, Manufacturing Sciences, Warehouse)

Education:

Typically requires an Associate’s or Bachelor’s degree in Microbiology, Biology, (Bio)Chemistry, Chemical Engineering or related field.

Experience:

4 to 6 years of related experience in a laboratory or commercial manufacturing setting with an Associate’s degree.

2 to 4 years of related experience in a laboratory setting with a Bachelor’s degree.

At least 1 year of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required.

At least 2 years of experience with oligo synthesizers and HPLC purification systems is required.

Occupational Demands:

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Visually inspect components and final kits for compliance and specifications. Close vision (20 inches or less) will be utilized and some color identification will be required. Frequently required to perform reaching, bending, stooping or kneeling motions. Operators may be required to walk and stand for a considerable amount of time. Operators frequently use hands/fingers to handle or feel, open tightly sealed containers/tanks, and utilize hand tools. Operator will occasionally climb step stools/ladders as needed. May frequently or continuously lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight. May occasionally lift, carry, push, pull or otherwise manipulate objects up to 50 pounds in weight. May move heavier (greater than 50lbs) objects and/or materials using carts or pallet jacks.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Req ID: 217470

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