Specialist QA Systems

Company: Bayer AG
Location: Berkeley
Posted on: September 17, 2020

Job Description:

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

The primary responsibilities of this role, Specialist Quality Assurance Systems, are to:

Work as a quality representative on the project team;

Execute the project to plan;

Work within Quality and with other functional areas to meet timelines safely and compliantly;

Challenge assumptions appropriately;

Review and Approve project documentation (URS, Field Solution, Factory Acceptance Test, Site Acceptance Test, Installation & Operational Qualifications (IOQ) protocols, etc);

Author, review or approve manufacturing documentation required for the project (Standard Operating Procedure,Batch Production Record (BPR), process descriptions, risk assessments), with adherence to platform process but with strong focus on flexibility and adaptability;

Participate in interviews of job candidates and provide feedback on the candidates;

Work with the site team on establishment of robust processes for integration of Cell Culture Technology Center (CCTC) with existing site systems e.g. Quality Assurance (QA) documentation, change management through BASICS, deviation and Corrective Action/Preventive Action (CAPA) management in Dev@Com.;

Support tech transfer of new product(s) in parallel with project;

For post Project: Support daily manufacturing activities to meet production plan;

Review reports to assure that deviations are investigated in a compliant and timely manner;

Review and approve change applications to ensure completion in a compliant and timely manner;

Acts as a technical resource to support review of change applications;

Identify and escalate product quality issues to quality management;

Support maintenance of departmental metrics for area (weekly, monthly, and annually) and release cycle time targets;

Review of manufacturing documentation with focus on Good Documentation Process (GDP) and compliance;

Work within the defined compliance management system applicable to CCTC;

Represent QA during audits and provides audit responses to observations;

Review and approve of documents for qualification of materials and suppliers;

Demonstrate commitment to safety by engaging in all safety initiatives;

Participate in an environment of continuous process improvement and take action accordingly;

Provide quality support for implementation of new equipment;

Provide off-hour quality support and on-call emergency response when required;

Be able to work an off-shift schedule as needed, including weekend cover.

For compliance: Review and approve Change Applications within CCTC to ensure timely and compliant changes;

Review documents associated with Deviations and CAPAs within CCTC;

Work to meet all compliance commitments, as needed;

Help prepare the plant for inspection by external authorities and internal audits;

Support tracking of deviation generation in the department to ensure that adverse trends are addressed quickly and effectively;

Lead and / or participate in investigations to resolve deviations, determine root causes of discrepancies and write-offs and implement effective corrective actions to minimize reoccurrence;

Assess process impact of proposed changes in materials and equipment.

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 with at least six years of industry experience, or master’s degree with zero to two years of industry experience, or Ph.D. with no prior industry experience, or equivalent combination of education and experience;

Experience in some or all of the following manufacturing areas: Cell Expansion, Cell Culture, Purification, Media & Solution Preparation and Weigh/Dispense;

Proven ability to partner to resolve issues;

Experience with regulatory and Certified Good Manufacturing Practice requirements for pharmaceutical manufacturing;

Knowledge of pre and post-viral segregation requirements;

Knowledge of applicable agency regulation (FDA, European Medicine Agency etc.) to ensure inspection readiness of department;

Understanding of some or all Quality Assurance topics relating to: qualification and validation, deviation management, change management, compliance management system requirements, material qualification and release, and auditing;

Understanding of department & business processes;

Ability to write or follow written standard operating procedures, good manufacturing practices, safety regulations, and corporate policies;

Must be able to work in an independent manner;

Experienced with business systems such as Statistical Analysis Plans, LMS, Manufacturing Execution System, Dev@Com (DR/CAPA System), Valgenesis, BASICS, etc.;

Experienced with Microsoft Office, Outlook, Visio, Microsoft project, and web search engines;

Effectively employ all methods of communication (oral, written, presentation) to provide ongoing communication to employees or teams;

Demonstrates a clear bias for action: Acts with a sense of urgency;

Delivers on commitments;

Persists in the face of challenges and setbacks;

Consistently follows through.

Demonstrates composure under pressure and maintains positive outlook: Demonstrates appropriate level of adaptability and flexibility;

Makes logical decisions under pressure and with limited information available;

Clearly articulates decision making processes.

Challenges the status quo and embraces change: Adapts easily to meet business needs;

Actively looks for opportunities to improve;

Works easily with limited information.

Establishes open, candid, and trusting relationships: Demonstrates integrity by standing by decisions;

Shows consistency between words and action;

Works to achieve department goals and objectives;

Treats colleagues from all levels as internal customers.

Interacts and responds to requests respectively: Gains insight into customer needs;

Represents own interests while being fair to others and their areas;

Partners to get work done;

Credits others for their contributions and accomplishments.

Preferred Qualifications:

Experience with single use technology and mAb production;

Previous experience in technology transfers or New Product Introduction.

Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country: United States

State: California

Location: Berkeley

Reference Code: 177003

Functional Area: Quality

Entry Level : Professional

Bayer has heard reports of fraudulent recruiting activities. If you are the target of what you believe to be fraudulent recruiting activity please get in touch with us.

Keywords: Bayer AG, Berkeley , Specialist QA Systems, Other , Berkeley, California