Quality Specialist II
Company: Katalyst HealthCares & Life Sciences
Posted on: May 27, 2023
- Perform sampling, and inspection on incoming commercial and
experimental/clinical raw materials, components, and
- Perform raw material component review to ensure correct
quantities, labeling and visual appearance.
- Oversee the administration of prompt event evaluation,
investigation, closure and follow-up of process/equipment
discrepancies and related areas as well as identify opportunities
for continuous process improvements.
- Comprehend and adhere to all related SOPs, company policies,
cGxPs, and regulatory requirements.
- Comprehend and adhere to all pertinent Health and Safety
regulations, policies and procedures and the required use of all
approved and issued Personal Protective Equipment.
- Execute activities/tasks (i.e., sampling, cleaning, packaging
component testing.) in accordance with approved SOPs, schedules and
communicates expected processing times for incoming raw materials,
components, and intermediates to appropriate Warehousing, Planning,
Operations, Pharm Tech, and Quality management. Efficient and
proactive in executing assigned activities.
- Maintain current training status and close all training gaps in
a timely fashion.
- Prepare and maintain tracking/testing systems, (i.e., LIMS,
SAP, Logbooks, OCR, etc.) which are used for testing and to reflect
status of samples. Reports status to appropriate laboratory,
manufacturing and planning groups at pre-determined intervals.
- Provide timely day-to-day decisions on compliance related
issues in Production, Warehouse/Distribution, Facilities, Incoming
QA, Quality Control and Stability areas based on expertise and
collection of independently gathered information.
- Assess accuracy and compliance of plant SOPs as a SOP reviewer
and approver and works with SOP author for timely approvals.
- Communicate daily with supervision and others within work group
as related to specific job function and demonstrate the ability to
communicate with others outside of work group.
- Demonstrate a level of consciousness to safety and health
related activities as evident by the daily application of
requirements specific to job function; Recognize safety and health
related issues and report to supervision.
- Support and maintain an environment that fosters communication
and teamwork within Quality Assurance and related departments.
- Perform other related assignments and duties as required and
- Basic understanding of applicable regulatory requirements as it
relates to job function demonstrated by adherence to policies and
- Basic ability to perform computer transactions related to job
functions demonstrated by right first-time measures.
- Ability to perform job function using appropriate
instrumentation and applicable techniques demonstrated by efficient
and accurate completion of work.
- Ability to apply technical knowledge and experience in
performing job functions as is displayed through independence in
daily performance of work.
- Ability to apply and evaluate systems and procedures for
improvement opportunities demonstrated through discussion of
recommendations with supervision.
- Ability to overcomes obstacles to achieve results as indicated
by ability to resolve issues and meet timelines.
- Demonstrate application of industry best practices and specific
regulatory requirements for evaluation of systems and procedures
for improvement opportunities and communicates results and ideas to
supervision on a regular basis.
- Ability to troubleshoots and recommend improved methods or
techniques of performing job function or utilizing instrumentation
demonstrated by ability to achieve results, gain right first-time
output, and improve efficiency.
- Ability to utilize multiple IT systems required for job
performance and utilize reports for analysis demonstrated by
consistent right first-time results and independent resolution of
- Recommend solutions to issues related to the job function in a
- Troubleshoot and provide immediate solutions for issues related
to job function.
- Execute corrective actions to prevent reoccurring
- Demonstrate ability to communicate with others outside of work
group as related to the specific job function.
- Contribute to functional areas outside of work group
contributing expertise as related to the specific job
Keywords: Katalyst HealthCares & Life Sciences, Wilson , Quality Specialist II, Professions , Wilson, North Carolina
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