Master Associate, Quality Assurance, Swing Shift, Fremont CA

Description

Works independently to provide quality assurance oversight activities of any area assigned of the business responsible for adhering to compliance with cGMP´s, regulatory, industry, and corporate requirements including critical utilities, (e.g. WFI, Steam, Automation, equipment, HVAC, etc.), warehouse, manufacturing processes, inspection, labeling and packaging, batch record review, batch disposition, new product introduction/product transfer, external quality and laboratories .

Demonstrates an excellent level of judgment and discretion in the timely identification and investigation and resolution of events impacting the Quality of products and processes. Quality oversight responsibilities include ensuring adherence to SOPs and requirements, providing concurrence on corrective and preventive action plans (CAPA)/Deviation management, providing quality approval of impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet all requirements. Ensures Quality decisions are made, with consultation from Quality colleagues, which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.

 As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

The shift for this role is Swing Shift Monday-Friday 2pm-10:30pm

Compensation Data

This position offers a base salary typically between (75,000) and (122,000).  There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. 

Requirements

• Bachelor´s degree, from an accredited institution, in Biology or Chemistry is preferred (or closely related degree with these core courses as the foundation) plus two (2) to four (4) years of Quality Assurance experience.
• In lieu of a Bachelor´s Degree, High School Diploma with a minimum of six (6) to eight (8) years biopharmaceutical industry experience with cGMPs in areas described in this profile.
• Exercise independent judgment and decision making abilities required.
• Demonstrated knowledge of relevant regulations and guidances. (ie. cGMPs, SOPs, Protocols).
• Demonstrated problem-detection and problem-resolution skills required.
• Ability to facilitate conflict resolution and negotiation skills.
• Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Must possess excellent verbal and written communication skills; good interpersonal skills.
• Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned. For example, Manufacturing Operations QA requires full gowning and gloving certification, ILP will require inspection validation requirements are met, lab-based areas will require bench training and that laboratory protocols and dress code are adhered to.
• Visual Demands - Must be able to read and see clearly. Employees assigned to ILP will be required to participate and have acceptable results from vision testing including color -blindness.
• Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.
• Attendance / Schedule - Attendance requirements are based on BIFI general attendance policies.

Desired Skills, Experience and Abilities

• Capability to establish good relationships with others who have different values, cultural styles and perspectives.
• Setting high and ambitious goals and standards for oneself and others, continuously raises the bar.