Bulk Formulation Chemist II (527709)

Would you like to join an international team working to improve the future of healthcare Do you want to enhance the lives of millions of people Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop produce and market innovative medicines solutions and services in more than 110 countries and regions.

Grifols Diagnostic in San Diego CA is seeking a Bulk Formulation Chemist II. The Bulk Formulation Chemist II will be responsible for the manufacture of bulk clinical and commercial kit reagents. Responsible for sub-assembly formulation raw material prep and/or processing QC testing reagent or component formulation and some in-process testing. Participate in transfer support activities and continuous improvement on existing processes. May be assigned to one or more functional Manufacturing areas.

We are seeking individuals with varying levels of experience based on their education. Individuals with a Bachelors degree must have 1 to 3 years of related experience in a laboratory setting. Individuals with an Associates degree must have 2 to 4 years of related experience in a laboratory or commercial manufacturing setting. Individuals with High School diplomas must have at least 4 to 6 years of experience in a laboratory or commercial manufacturing setting. At least 1 year of experience with Good Documentation Practices (GDP) Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required

Primary responsibilities for role:

• Responsible for the staging of raw material and formulation of reagent bulks or constituents.
• 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 cGMP.
• Maintains detailed and accurate device history records with cGMP.
• Completes and forwards device history records for review in a timely manner.
• General manufacturing area housekeeping includes cleaning of labware equipment shelves benches and sinks and removing trash.
• Ensure proper transportation handling and disposal of hazardous bio-hazardous and/or infectious substances.
• Operates and calibrates as needed all general lab equipment.
• Follows all safety rules.
• Maintains accurate and complete training records.
• Maintains and archives Manufacturing log sheet records.
• May be working on processes and observed during audits including ISO FDA and internal audits.
• Open and close work orders.
• Responsible for maintaining a laboratory environment in one functional area.
• Act as material transfer coordinator.
• Proactively identify operational problems that could lead to scheduling and output conflict and potential solutions.
• Aid metrology liaison: gather from the lab the equipment due for calibration on a monthly basis.
• Verify or perform cycle counts and verify discrepancy conduct investigation and complete report.
• Identify new opportunities for 5S.
• Identify and participate in process improvement projects.
• QN investigations: provide information to the QN author as needed.

Additional Responsibilities:

Cross-functional communication participation. Responsible for flushing water ports and eyewash stations. Adhere to target manufacturing timelines. Attentiveness and openness to learn new processes. Maintains implemented 5S. Performs refrigerator/freezer maintenance. Perform general equipment maintenance operation and calibration. Assists Oligo Synthesis Operations or Fill team as needed.

Knowledge Skills and Abilities:

• Demonstrated job specific technical knowledge.
• Working knowledge of Microbiology Biology or Chemistry
• Working knowledge of laboratory safety and record keeping.
• Working knowledge of ERP system.
• Working knowledge of GDP GMP. Blood Borne Pathogen Training.
• Intermediate knowledge in the operation of analytical balances pipettes filter integrity testers peristaltic pumps water baths and spectrophotometers.
• Basic level experience in the set-up and operation of reagent bulk tanks and mixers.
• Intermediate-level knowledge on the operation of complex laboratory equipment and processes.
• Working knowledge of Microsoft Office software.
• Attention to detail good organizational skills and team-oriented.
• Ability to follow oral and written instructions.

Education:

Typically requires High school Diploma or Associates (AA) or Bachelors degree in Microbiology Biology Chemistry Chemical Engineering or related field.

Experience:

• 4 to 6 years experience in a laboratory or commercial manufacturing setting with a High School Diploma.
• 2 to 4 years of related experience in a laboratory or commercial manufacturing setting with an Associates degree
• 1 to 3 years of related experience in a laboratory setting with a Bachelors degree
• At least 1 year of experience with Good Documentation Practices (GDP) Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required

Equivalency:

Depending on the area of assignment directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Example: If a job level typically requires an Associates degree plus 2 years of experience an equivalent could include 4 years of experience or a Bachelors degree.

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 accommodation 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.

Pay Scale

The estimated pay scale for theBulk Formulation Chemist IIrole based inSan Diego CA is$28.25 to $35.31 per hour. Additionally the position is eligible to participate in up to5% of the company bonus pool. We offer a wide variety of benefits including but not limited to: Medical Dental Vision PTO up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education experience skillset knowledge where the role is performed internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909 Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years and you can grow with us!

Location:NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

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