Employment Type : Full-Time
Job Opening for Batch Record Reviewer II, Fremont, CA - Client: Boehringer Ingelheim – BIUSA We are currently working on below mentioned i., e. Job Opening for Batch Record Reviewer II, Fremont, CA - Client: Boehringer Ingelheim - BIUSA. Please let me know if you are interested in applying for the same. General Information: Req#: 11383945 Description: Keywords: Skills and Experience:
Name: Batch Record Reviewer II
Type: Staffing
Status: Pending
Client: Boehringer Ingelheim - BIUSA
Reason: Staff Vacancy
Department: QUALITY ASSURN ANCE
Job Category: Clinical and Scientific
Job Title: Batch Record Reviewer II
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. The position performs logistical duties related to batch record review.
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
Education:
Requires a Bachelors degree, preferably in the life science Field plus a minimum of 2 years of professional experience in a GMP environment.
In lieu of a Bachelor's degree, will consider an Associate's degree plus 4 years of professional experience in a GMP environment environment or clean room assembly environment.
Required Skills:
CGMP
BATCH RECORD REVIEW
MANUFACTURING PROCESSES
EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
DOCUMENTATION
Additional Skills:
QA
GMP
LIFE SCIENCE
MS OFFICE
BATCH RECORD
BATCH RECORDS
INVENTORY
MICROSOFT OFFICE
PROCESS IMPROVEMENT
Languages:
English
Read
Write
Speak
Minimum Degree Required: Bachelor's Degree
Patents: No
Publications: No
Veteran Status: No
# of Positions: 1
Location: Fremont, CA, 6701 Kaiser Drive,