GreshamRecruiter Since 2001
the smart solution for Gresham jobs

Assistant Manager of Quality

Company: CSL Plasma
Location: Gresham
Posted on: January 12, 2021

Job Description:

About CSLWith operations in 35+ nations and -27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job Description--- Ensure center is "inspection ready" at all times by managing adherence to Standard Operating Procedures (SOPs), compliance policies and the quality system, utilizing sound Quality principles, self-inspection learnings, non-conformity discovery and appropriate remediation. Prepare regular reports to center, area and corporate quality management as to the state of quality and systems at the center.--- Manage site Quality Control program including but not limited to calibrations management, monitoring of compliance to defined processes e.g. sampling, competency checks, Key Performance Indicators (KPIs), trending and analysis of KPIs, root cause and failure mode impact assessment and change management.--- Lead and develop direct reports ensuring they are competently skilled to perform their QA roles. Lead by example; consistently motivate staff through education to high levels of competency that drive success in a dynamic and regulated environment. Upon proper review with center and quality management, recruit, hire, conduct performance reviews and enact corrective actions, up to and including termination.--- Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality.--- Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Report concerns or deficiencies to area personnel and/or area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies.--- Lead and function as the key quality representative for site supplier, customer and regulatory audits. Lead center review of findings, coordination of remediation (CAPA), if needed and successful closure of timely audits. Utilize quality tools and applications to facilitate understanding of issues and documentation.--- Maintain clean efficient work environment and ensure sufficient operating supplies and availability of forms, as needed. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine audits of internal procedures and documentation, as necessary. Promote safety in all actions.--- Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicate effectively with HR to ensure HR compliance and ensure center management is doing the same.--- Comply with all federal, state and local regulatory and company policies and procedures.--- Responsible for notification to the ADOQ for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification must be elevated to any of the following, Regional Director, Associate Director of QA, Divisional Director or Director of Quality Systems and Assurance.--- Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyper immune programs at the center if applicable.--- Lead investigations and deviations to determine root cause,correction/preventativeactions and effectiveness checks. Monitor CAPA's and effectiveness checks to ensure issues are resolved.--- Perform other job-related duties as assigned.Education--- Bachelor's Degree preferred--- Equivalent combination of education and professional work experience requiredExperience--- Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others, OR--- 1 year Quality experience (CSA/CSAb) required OR--- Completion of CSL Plasma Leadership Development programAdditional Comments--- Maintain company Technical Training certification--- Knowledge of ever-changing and complex government and industry regulations, and ability to monitor compliance with these regulations--- Monitor and manage entire financial responsibility of the center--- Proficient in EnglishWorking Conditions(physical & mental requirements)--- Ability to make decisions which have significant impact on the department's creditability, operations and services--- Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations--- Frequently exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens--- Overnight travel required up to 10% of the time--- Generally spends 80% of the time standing and walking and 20% of time sitting--- Occasionally lift and carry up to 25 lbs.--- Exposure to hot and cold temperatures, sudden temperature changes working with freezers and various odors--- Exposure to human source products and various chemicals including isopropyl, ethyl alcohol, carbon dioxide, iodine, bleach, germicide solution, etc.--- Required to wear Personal Protective Equipment while performing specific tasks or in certain areas--- Fast paced environment with frequent interruptionsAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.Job Description--- Bachelor degree in scientific discipline/life sciences or related discipline--- 5+ years' experience related to quality and regulatory/ Plasma industry experience--- Demonstratedleadership/supervisoryexperience--- Knowledge of government and industry regulations#CB

Keywords: CSL Plasma, Gresham , Assistant Manager of Quality, Executive , Gresham, Oregon

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Customer Success Manager
Description: Cvent is an exciting, fast-growing tech company that provides industry-leading software to more than 300,000 event professionals and hoteliers around the world. The economic significance of our industry (more...)
Company: Lanyon Solutions
Location: Portland
Posted on: 01/19/2021

Director, Product Design
Description: Your OpportunityWe're looking for a Director of Product Design to join the New Relic Full-Stack Observability team to help lead our premier product experience. You'll lead the design of product experiences (more...)
Company: New Relic
Location: Portland
Posted on: 01/19/2021

Director of Nursing - Registered Nurse RN - Relocation Available
Description: Job Description: We invite you to join our compassionate and dedicated team at Coast Fork Nursing Rehab : Competitive Salary - Relocation Package - Bonus Program: For more information about this position (more...)
Company: Prestige Care, Inc.
Location: Portland
Posted on: 01/19/2021


Director of Product Marketing
Description: Location Details: Mozilla---s North American office locations include San Francisco, CA, Portland, OR and Toronto, Canada. We are also open to you working from your home office anywhere in the US or Canada (more...)
Company: Mozilla
Location: Portland
Posted on: 01/19/2021

Maintenance Manager
Description: Job Summary: In a safe, efficient and professional manner the Maintenance Manager will support the Regional Business Manager in the preventative, corrective, and general maintenance for the Client. Other (more...)
Company: Modis
Location: Tualatin
Posted on: 01/19/2021

Office Manager
Description: We are currently seeking a full-time Office Manager/Program Specialist for our Allied Health Services Belmont facility. Hours are Monday through Friday 6:00am-2:30pm.Allied Health Services Belmont, a (more...)
Company: Belmont Comprehensive Treatment Center
Location: Portland
Posted on: 01/19/2021

Digital Marketing Manager
Description: Description: br Arlon Graphics, LLC is a cast vinyl manufacturing company in the business of creating innovative material for visual expression. Founded in 1958, Arlon Graphics manufactures and markets (more...)
Company: Arlon Graphics
Location: Portland
Posted on: 01/19/2021

Program Manager
Description: Hardware Program Manager ur client is searching for a Hardware Program Manager for our Operations Team. This person must have a track-record of managing cross functional hardware programs across business (more...)
Company: VanderHouwen
Location: Portland
Posted on: 01/19/2021

Workday Financials - Consulting Manager - Higher Ed & Healthcare
Description: Workday Financials - Consulting Manager - Higher Ed HealthcareJob ID: JR-0000605Category: Healthcare Consulting, Higher Education ConsultingOpportunity Type: ExperiencedCountry: United StatesOffice (more...)
Company: Huron Consulting Group
Location: Portland
Posted on: 01/19/2021

Director Operations
Description: OverviewThis highly visible leader will be responsible for managing and assisting in the operations of several ambulatory surgery centers and assisting in the strategic vision for the market. This role (more...)
Company: Surgical Care Partners
Location: Portland
Posted on: 01/19/2021

Log In or Create An Account

Get the latest Oregon jobs by following @recnetOR on Twitter!

Gresham RSS job feeds