Documentation Specialist I

  • Contractor
  • Full-Time
  • Fremont, CA
  • Splintpharma
  • Prefferd visa: OPT, CPT, F1, H4, Have H1 Visa, Need H1 Visa, EAD
  • Posted 1 year ago – Accepting applications
Job Detail
  • Offerd Salary $ 35 - $ 40
  • Required Position 2-4 hires
  • Experience 0-3 Years Required
Job Description

Job Opening for Documentation Specialist I, Fremont, CA : Client: Boehringer Ingelheim - BIUSA
We are currently working on below mentioned i., e. Job Opening for Documentation Specialist I, Fremont, CA: Client: Boehringer Ingelheim - BIUSA. Please let me know if you are interested in applying for the same.
Name: Documentation Specialist I 
Type: Staffing
Status: Pending
Client: Boehringer Ingelheim - BIUSA
Start: 08/15/2022

Description:
Reason: Replacement
Department: MFG CELL CULTURE
Job Category: Professional
Job Title: Documentation Specialist I
Duties: This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs duties under limited supervision and according to standard operating and manufacturing procedures. It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met.
Independently executes (paper/electronic) batch record review
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
Skills: Demonstrated proficiency in MS Office programs and associated computer programs.

Technical knowledge of manufacturing systems, methods, and procedures.
Must have excellent written and verbal communication skills.
Awareness and understanding of Manufacturing processes


Keywords:
Education: Requires a Bachelor’s degree, preferably in the life science Field plus a minimum of 2 years of professional experience in a GMP environment.

Location: Fremont, CA, 6701 Kaiser Drive

Job Requirement

Job Opening for Documentation Specialist I, Fremont, CA : Client: Boehringer Ingelheim - BIUSA
We are currently working on below mentioned i., e. Job Opening for Documentation Specialist I, Fremont, CA: Client: Boehringer Ingelheim - BIUSA. Please let me know if you are interested in applying for the same.
Name: Documentation Specialist I 
Type: Staffing
Status: Pending
Client: Boehringer Ingelheim - BIUSA
Start: 08/15/2022

Description:
Reason: Replacement
Department: MFG CELL CULTURE
Job Category: Professional
Job Title: Documentation Specialist I
Duties: This position leads all paper/electronic batch record review that is related to manufacturing of drug substance in a multi-product facility. The position performs duties under limited supervision and according to standard operating and manufacturing procedures. It contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines are met.
Independently executes (paper/electronic) batch record review
- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.
Skills: Demonstrated proficiency in MS Office programs and associated computer programs.

Technical knowledge of manufacturing systems, methods, and procedures.
Must have excellent written and verbal communication skills.
Awareness and understanding of Manufacturing processes


Keywords:
Education: Requires a Bachelor’s degree, preferably in the life science Field plus a minimum of 2 years of professional experience in a GMP environment.

Location: Fremont, CA, 6701 Kaiser Drive

Required skills