Overview
QC Tech 1 Jobs in Vale, OR at EP Minerals LLC
Position Title: Quality Assurance and Compliance Specialist II
FLSA: Full-time, Non-Exempt (hourly) plus benefits
Salary: $34.28 per hour
Schedule: Monday – Friday; 8:00am to 5:00pm
Location: SDBB HQ – 3636 Gateway Center Ave, Ste 100, San Diego, CA 92102
Are you passionate about making a real difference in your community? Are you looking for a job where you can contribute to a meaningful cause and grow professionally? If so, San Diego Blood Bank invites you to join our dynamic & diverse team dedicated to the mission of saving & improving lives through blood and biotherapies.
WHY CHOOSE SDBB?
At San Diego Blood Bank, we provide Southern California regional hospitals with a wide range of blood banking services. These include blood collection, component preparation, plateletpheresis, plasmapheresis, leukapheresis, washed blood, frozen blood, autologous storage, designated donation services, and a reference laboratory. San Diego Blood Bank’s Cord Blood Banking Program provides lifesaving stem cell transplants to patients worldwide.
Founded in 1950, San Diego Blood Bank has been an important institution in the San Diego community for decades. Today, SDBB is continuing to grow to meet the changing needs of our healthcare community.
San Diego Blood Bank is a 501(c)(3) nonprofit organization also operating as Southern California Blood Bank. We serve hospitals in San Diego, Los Angeles and Orange Counties. We are the primary blood provider to Rady Children’s Hospital-San Diego and the safety net for hospitals in our region. Every year, more than 150,000 units of blood provided by San Diego Blood Bank are transfused into patients of all ages, socio-economic and ethnic backgrounds throughout Southern California. These patients are struggling with life-threatening medical conditions including cancer and other blood disorders, severe burns, organ transplants, emergency surgery, trauma, childbirth complications and more.
WHAT YOU NEED TO KNOW (Job Summary)
Under the direction of the Manager, Quality & Regulatory Affairs, the Quality Assurance and Compliance Specialist II participates in maintaining a Quality Management System that supports the manufacture of FDA-regulated biologic blood, cell and tissue products and other related regulatory activities. The Specialist ensures that performance and quality of products conform to established standards and regulatory requirements.
WHAT YOU WILL BE DOING TO MAKE A DIFFERENCE (Key Responsibilities):
Prepares audit tools, conduct internal audits, submit audit report and perform follow up on related corrective action plans.
Perform regulatory review of standard operating procedures, validations and other regulated documents.
Assist in the maintenance and improvement of the San Diego Blood Bank quality and compliance programs.
Develop and revise policies, standard operating procedures (SOPs) and other documents.
Host and/or assist departments in preparing for external inspections.
Participate in regulatory, accreditation and third-party inspections.
Assist with focused audits as identified by new process design, problem management, and/or external inspections.
Perform follow up on corrective action plans submitted in response to problem management, supplier issues, product complaints, and other issues as directed by management.
Assist with the development of quality metrics and key performance indicators for regulated areas of the blood bank.
Assist with new/renewal applications for accreditation, licensure, certification, registration and waivers, as well as FDA license amendments.
Assist with donor record audit reviews, including relevant investigation and resolution of errors or discrepancies.
Assist with recall, market withdrawal, regulatory and consignee notification.
Assist with the development of performance improvement initiatives and implementation processes.
Participate in corrective and preventive action teams, assist with investigation and root cause analysis and verify that actions are implemented and effective.
Initiate Quality Incident Reports after identifying errors and quarantine products as needed.
Perform final review of Quality Incident Reports as needed.
Assist with the investigation of Quality Incident Reports within the scope of his/her knowledge as needed.
Educate staff on laws, regulations and standards that govern the San Diego Blood Bank.
Ensure compliance with all applicable state and federal laws and regulations and with the standards of the accrediting/certifying agencies.
Participate in appropriate departmental meetings, and attend other meetings as assigned.
Represent the San Diego Blood Bank at conferences and meetings as assigned.
Enhance professional growth and development through participation in educational programs, current literature review, in-service meetings and workshops
Understands and adheres to the policies and standards as developed as part of the San Diego Blood Bank Compliance Program.
Performs other related duties as assigned or requested.
WHAT YOU NEED TO SUCCEED (Minimum Qualifications)
Bachelor’s degree in related field or discipline.
ASQ, CPHQ, Health Care Compliance Certification Board (CHC, CHRC), or similar certification required or must be obtained within two (2) years of hire.
Minimum of four (4) years of experience working in a Quality Assurance or Regulatory Affairs department. Experience should include participation in FDA and State site inspections, experience with GMP requirements, application of quality assurance principles, and healthcare compliance.
Must have ability to move around office and stand for prolonged periods.
Must be able to work on computer 4 – 8 hours a day.
Must have ability to travel to mobile or fixed collection sites and to off-site meetings.
Ability to perform tasks per GMP regulations including following detailed SOPs, maintaining training, deviation reporting and good documentation practices.
Ability to perform accurate detail-oriented work.
Ability to organize activities effectively, use effective problem-solving techniques and make sound decisions.
Ability to communicate effectively with internal and external customers.
Must be able to establish priorities and multi-task.
Ability to work well with others.
Must possess good verbal and written communication skills and teaching abilities.
Must have good knowledge of standards and regulations that apply to blood banking, umbilical cord banking, cellular therapy services, clinical laboratory, and clinical research.
Proficient in Microsoft Suite applications (Excel, Word, PowerPoint).
WHAT WILL GIVE YOU THE COMPETITIVE EDGE (Preferred Qualifications)
Advanced degree preferred
Experience in a blood bank setting preferred.
Additional Experience in cellular therapy services, umbilical cord banking, molecular testing and/or clinical research preferred.
BENEFITS FOR YOU
We take care of you, while you take care of others. As a mission-based organization, we believe our team needs great support to do great work. Our comprehensive benefits help you in balancing home and work. With our resources and perks, you have amazing possibilities at the San Diego Blood Bank including:
Employees working 30 or more hours per week are eligible for employer sponsored health benefits (Medical, Dental, & Vision plans)
Earn up to 120 hours of paid vacation in your first year.
7 paid Holidays + 1 personal holiday provided annually.
40 hours of paid sick time provided annually.
403b retirement plan with 3% employer match starting on your first day.
Employee Assistance Program – Free for employees and their families
Service Awards and recognition.
Apply now! Join our team to make a difference every day.
The San Diego Blood Bank is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.Show more
Title: QC Tech 1
Company: EP Minerals LLC
Location: Vale, OR
