Batch Record Reviewer II
Compli

Job Info

---

Batch Record Reviewer II - Bay Area

(Pharmaceutical/Biotech)-Competitive Salary, Work/Life Balance!

On-Site / Pay W-2

Previous Pharmaceutical/Biotech/Medical Device experience is mandatory for these roles.

Are you looking to be a part of a close-knit work community? Do you have experience in the Life Science industry? Will you represent Compli, LLC as an experienced Batch Record Reviewer II for our pharmaceutical manufacturing, biotech, and medical device client projects? Do you enjoy traveling the country and making a difference? If so, this could be the right opportunity for you!

Important: Our Client has mandated COVID-19 vaccination for their workforce, effective October 1st, 2021. All external personnel providing services to Compli' s client are required to comply with this requirement.

Description

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

Education

• Requires Bachelor's 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 degree plus 4 years of professional experience in a GMP environment or clean room assembly environment.

Required Skills

• MANUFACTURING PROCESSES
• BATCH RECORD
• CLEAN ROOM
• GMP
• EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS Additional Skills:
• ASSEMBLY
• LIFE SCIENCE
• QA
• BATCH RECORD REVIEW
• DOCUMENTATION
• PROCESS IMPROVEMENT
• MICROSOFT OFFICE
• BATCH RECORDS
• INVENTORY
• Languages:
• English

Compli, LLC was founded in 2001 to provide commissioning, validation, and regulatory support services, CQV, asset management, reliability engineering, and staff augmentation services to the life sciences industry. We serve pharmaceutical companies across the U.S. Regarding regulations and compliance, it has never been more important to understand the documentation and quality assurance activities as they relate to vendors, engineering, construction, and contractors, which is why clients trust the Compli team.

Perks of the Job:

• Competitive Pay commensurate with experience
• Work / Life Balance
• Working with a small, close-knit team where you are valued as an individual
• A learning environment and continuous advancement opportunities

Feel overqualified? Feel underqualified? Apply anyway if this sounds like the fit you are looking for! We have flexibility in how we hire the role.

To learn more and APPLY NOW: http://www.ucompli.com/careers

Agencies, Compli welcomes your qualified candidates.

Please email compli-opportunities@ucompli.com to establish a relationship with our firm. We are an equal opportunity employer M/F/D/V

Job Keywords: United States, San Francisco, CA, Surrounding Area, Freemont, CA, California, Bay Area, Quality Assurance, Batch Record, QA, Clean Room

This job has expired.