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Bulk Formulation Chemist III

3 months ago

CASan Diego, United States GRIFOLS, S.A. Full time

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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.

Summary:

Grifols Diagnostics Solutions is seeking a Bulk Formulation Chemist III to support our Manufacturing Team in San Diego, CA. The Bulk Formulation Chemist III is responsible for the manufacturing of bulk clinical and commercial kit reagents, 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. Assist in the mentoring and training of new hires or team members.

 

In order to be successful in this position, you must have at least 3 to 5 years of experience in a laboratory or commercial manufacturing setting (with a Bachelors), 4 to 6 years of experience in a laboratory or commercial manufacturing setting (with an Associates). At least 2 year of experience in GDP, GMP, and ISO 13485. And at least 2 years of Bulk/Reagent formulation experience 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 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.
  • 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 laboratory environment in one functional area.
  • Responsible for delegating material transfer activities.
  • Perform process troubleshooting on instruments and equipment used in bulking processes.
  • Identify the appropriate departments and submit workorders as needed for equipment, parts and instruments.
  • Initiate Quality Notifications (QN) and assist investigation.
  • Perform proposed document updates and edits.
  • Support document/SOP revisions by performing a second reviews.
  • Implement new areas or ideas for 5S.
  • Lead process improvement projects through teams within the department or a cross-functional project teams.
  • Act as metrology liaison: own instruments and equipment while collaborating with engineering to complete calibrations.

 

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

 

Knowledge, Skills, and Abilities:

Demonstrated job specific technical knowledge. 

Working knowledge of Microbiology, Biology, or Chemistry.

Working knowledge of laboratory safety and record keeping system. 

Working knowledge of ERP system.

Working knowledge of GDP, GMP. Blood Borne Pathogen Training.    

Intermediate to advanced knowledge in the operation of analytical balances, pipettes, filter integrity testers, peristaltic pumps, water baths and spectrophotometers. 

Intermediate to advanced level experience in the set-up and operation of reagent bulk tanks and mixers.       

Intermediate to advanced-level knowledge on the operation of complex laboratory equipment and processes.       

Intermediate knowledge of Microsoft Office software.    

Attention to detail, good organizational skills and team oriented.     

Ability to follow oral and written instructions.   

 

Education:

Typically requires Associate's (AA) or Bachelor's degree in Microbiology, Biology, 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
  • 3 to 5 years of related experience in a laboratory setting with a Bachelor’s degree
  • At least 2 year of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required 
  • At least 2 years of bulk/reagent formulation experience 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.

 

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.                                                    

 

Pay Scale:

The estimated pay scale for this Bulk Formulation Chemist III role based in San Diego, California is $31.08 to $38.84 per hour. Additionally, the position is eligible to participate in up to 5% 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 

 

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Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

 

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.  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.

 

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

 

Learn more about Grifols