The Quality Specialist II role is key to our commitment to high quality and innovative growth. This position will focus on continual improvement and change management while also fulfilling fundamental QA roles. The Quality Specialist II will execute Quality System continual improvement initiatives stemming from customer audits, internal audits, CAPAs, and strategic planning exercises. These initiatives are intended to improved quality, efficiency, productivity and compliance. The Quality Specialist II will work closely and collaboratively with the Quality team, Laboratory and Leadership staff on improvement projects while actively contributing to positive co-worker/customer relationships.
Job Responsibilities
• Lead the Corrective Action process in response to customer and internal audits and regulatory inspections, including but not limited to:
o Design and execute Corrective Action project plans, drafting response reports, setting timelines, and ensuring the completion of those actions on the communicated timelines.
o Design and implement actions in accordance to cGMPs and Element Bend’s Quality System such as writing Change Control documentation, revising procedures, performing re-qualification/validation activities, etc.
• Monitor the execution of the Change Management process and ensure changes to validated/qualified systems are adequately risk assessed and return the system to a qualified state after the change.
• Write and review SOPs and other procedures related to the Quality System with the goal of collaborating with other stakeholders, and continually improving our processes for increased modernization, efficiency, compliance, and to foster a continual improvement culture.
• Work with QA and Operations to close high risk compliance gaps to meet the goal of FDA inspection readiness.
• Perform quality oversight of the equipment management process (initiating new equipment, PMs, Calibrations, Qualifications, logbook reviews, etc.).
• Perform QA reviews of issue handling processes (IN/NCR/CAPA).
• Perform QA Reviews of project protocols and final reports.
• Evaluate processes for inefficiencies and opportunities to reduce non-value added tasks, increase user-friendliness, “engineer the human error out”, and reduce the costs of poor quality.
• Facilitate efficiency improvements being driven by lab staff and others by reviewing proposals for compliance and congruence with the Quality System.
• Ensure ongoing proficiency in the applicable regulations and standards (21 CFR Parts 11, 210, 211, 820; ISO 17025) and aid Element Bend’s continuing compliance.
• Monitor the timely completion of routine Quality System requirement tasks – support staff in completion, follow up on statuses, and provide updates to other QA and management staff.
• Become a subject matter expert in the EQMS platform user processes to 1) oversee the quality/compliance of the use and execution of processes in the system by users 2) help identify beneficial process improvements with the system; 3) train staff on the processes; and 4) continually support staff with questions & coaching related to the system.
• Responsible for the Training Program, conducting gap assessments, and working with staff toward improving training plan designs (i.e., Workstations, Onboarding, User Groups, etc.) for added value. May grow to include conducting Onboarding trainings of Quality System fundamentals.
• Assist QA management with changing needs, such as procedure improvements, customer and vendor Quality Agreements, Quality System Metrics, department strategic initiatives, etc.
• Participate in the Vendor Qualification Program including, but not limited to, QA Reviews of reoccurring vendor qualification activities and status changes and the conduct of on-site audits of high risk vendors (e.g., laboratory subcontractors).
• Interact in a collaborative manner with other team members to contribute to positive co-worker relationships, and maintain a high degree of integrity in all aspects of QA and IT activities.
FM 4335, Rev 1 Job Description Page 2 of 2
Revision History:
Revisions are managed in the EQMS
Issue Date:
30Aug2023
Reference: SOP 2011 Form Access Number: QSR-2402304
Competence Requirements
Education
Bachelor’s degree or higher in a scientific field
Experience
? NA
2+ years' experience working within a regulated Quality System/GMP environment required
Technical Knowledge
? NA
• Solid understanding of various industry regulations and standards
• Serves as an SME in at least one area for the department
Skills
? NA
• Good time management and prioritization
• Intermediate reading, writing, and math skills
• Strong attention to detail
• Good interpersonal skills
• Ability to plan daily work and arrange activities to meet deadlines
• Follows instructions, both written and verbal and able to provide clear instruction to others
• Good critical thinking skills
• Ability to work in a team environment
• Ability to draft technical documents without guidance
• Basic understanding of cost control measures and how 5S and SQDC principals impact lab flow
Qualifications
? NA
Training
? NA
Pay Details: $32.00 to $37.00 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
- Los Angeles City Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance for Employers
- San Francisco Fair Chance Ordinance