Qa Documentation Specialist - Berkeley, Ca 

Documentation Specialist – Berkeley, CA

Purpose

To deliver quality products and services on time to all internal and external customers by providing quality/compliance guidance. Monitoring processes and products to identify opportunities for continuous improvement. Providg direction for the issuance and management of procedures and batch records.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role are to:

• Review and approval of procedures and batch records using scientific principles as needed. Ability to retrieve and archive documents as required;
• Ensure required inputs from critical business partners (e.g. Quality Assurance, Quality Control, Technical Operations, Supply Chain) meet cGMP requirements within established timelines;
• Provide effective leadership in training and developing internal customers/stakeholders; Support workforce diversity, quality and safety;
• Represent QA in interactions with Manufacturing, QA, QC, Production Planning & Logistics, Bayer partners, Supplier Auditors/Inspectors, and regulatory agency inspections;
• Assist and may lead on special projects with moderate complexity.

WHO YOU ARE

Your success will be driven by your demonstration of our life values, more specifically related to this position, Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• Bachelor’s degree in a scientific discipline;
• 3 years of related experience in the biopharmaceutical industry with an emphasis in Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP regulated industry or equivalent combination of education and experience;
• Ability to understand the document control lifecycle process;
• Proven ability as a team player and leader;
• Excellent analytical and problems solving skills;
• Proven ability to express views and opinions;
• Listens well and accepts conflicting point of views;
• Detail oriented, good communication and interpersonal skills;
• Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines.

PREFERRED QUALIFICATIONS

• 6 years of related experience in the biopharmaceutical industry with an emphasis in Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP regulated industry or equivalent combination of education and experience;

Employees can expect to be paid­­­­­­­­­­­­­­­­­ a wage between $89,875.00 and $134,811.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This wage range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be open for applications until at least 5-13-24