Manufacturing Associate II

Location: 

CA-Emeryville, US

Contract Type:  Regular Full-Time
Area:  Manufacturing
Req Id:  455896

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

Purifies proteins in a regulated FDA licensed and ISO certified facility and performs cross-functional activities associated with downstream production runs in collaboration with Bulk Fill and QC testing groups.  The role may include special projects such as process development and validation activities where scientific research principles are applied.                                                                                        

                                                           

 Primary responsibilities for role:

Purify recombinant proteins to ensure commercial product demands are met: 

1. Works as part of the purification team to perform purification, filtration, and centrifugation operations according to standard operating procedures (SOPs).

2. Executes laboratory operations that includes dispensing of chemicals, volumetric and gravimetric measurements, making accurate dilutions, and preparing solutions.

3. Performs SAP duties that include cycle counting, reservations, issuing to process orders, and charging of expiring raw materials.

4. Performs equipment maintenance tasks, column packing, and column testing procedures.

5. Ability to multi-task and become proficient at purifying 14 different proteins and make conjugates.

6. Responsible for ordering raw materials and components, as required.

7. Promotes and maintains a safe and well-organized work environment and complies with safety procedures.

 

Follow regulatory requirements:

1. Adheres to valid manufacturing procedures, manufacturing operations, and current good manufacturing practices (cGMP) and ISO requirements.

 

Documentation:

1. Responsible for the completion and review of batch records and logbooks, which requires legible, clear, and concise data entry.

2. Completes all training documentation within a pre-defined timeframe.

 

Analytical Testing:

1. Analyzes in-process samples generated from purification activities.

2. Operates lab equipment such as pH meters, balances, centrifuges, spectrophotometers, HPLC systems, and densitometers.                                                        

                                                           

 

Additional Responsibilities:

Abides by the Quality Policy while contributing to organizational goals and metrics for Grifols Diagnostic Solutions.                                                    

 

Knowledge, Skills, and Abilities:

1. Works well in a team environment and utilizes project management skills to oversee completion of production lots.

2. Complies with cGMP and ISO requirements.

3. Maintains accurate documentation related to manufacturing processes.

4. Demonstrates leadership skills to train and guide fellow associates.

                                                                                                           

 

Education:

BA/BS in the sciences (Biology, Engineering, or related field).        

 

Experience:

• 2 years of experience with a BA/BS in a GMP environment.

• Must have knowledge of protein purification processes.

• Experience following and writing SOPs.

• Very good verbal and written communication skills.

• Computer knowledge required with experience using MS Word and Excel.

• Able to document work accurately and has excellent organizational skills.

• Experience with preparation of reagents following manufacturing SOPs.

• Delivers quality products and services on time to all customers, both internal and external.

• Must be attentive to detail.

• Effectively manages time.

• Considers how all daily manufacturing activities impact product quality.

• Monitor processes and products to identify opportunities for continuous improvement.

• Experience in project management is desirable.

• Knowledgeable of SAP, Kaizan, and 5S is desirable.

                                                                                                           

 

Equivalency:

Six years of relevant experience can substitute for a degree in the sciences.                                                                                 

 

Occupational Demands:

Able to lift and push up to 35 pounds.

 

                                                             

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.

 

Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters 

 

Learn more about Grifols