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AppleOne
Quality Control Analyst I
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What they do
A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
$69,465 / year median in New York
-13% projected decline
Job Description
This role leads and documents quality control investigations in a pharmaceutical laboratory, including out-of-specification results, laboratory errors, equipment failures, and test method issues. The position works with QC, QA, customers, and cross-functional teams to identify root causes, develop effective CAPAs, meet investigation deadlines, maintain compliance with cGMPs and SOPs, and drive critical investigations to closure.
Qualifications:
- Bachelor's with major in Chemistry or related scientific discipline with a minimum of 6 years of experience in a QC laboratory environment OR equivalent combination of relevant education and experience may be substituted as appropriate
- Investigations experience including root cause analysis, writing, and CAPA identification Monday - Friday 8am-5pm
Responsibilities:
- Work with QC and cross functional team as needed to meet required QC investigation deadlines in a proficient manner, while driving to root cause, and identifying the appropriate & effective corrective and preventive action.
- Ensure QC investigations are initiated in a timely manner, initial impact completed and submitted for QA reviews within stipulated timeframes
- Conduct and document investigations as needed, while also working with customers as required.
- Conduct, and document OOS investigations, including coordination with customers as required by quality agreements and regulatory commitments.
- Apply 6M, 5 Why or fishbone analysis to drive root cause
- All investigations will follow procedures in accordance with cGMP's.
- Work with the team to document and drive critical investigations to closure.
- Maintain metrics for the laboratories to identify CAPA opportunities including, analyst error rate, equipment failure rate, and test method issues.
- Ensure all investigations are executed in full compliance with cGMPs, Curia SOPs, and global quality standards.
- Work with the team to develop investigation strategies to meet customer commitments and requirements.
- Provide investigation updates to cross functional areas and management, as required.
- Develop an expertise in documenting investigations and create templates to use for ease of reference and consistency.
- Identify CAPA's and update training modules to reduce analyst error rate
- Work independently and with the QC team as the primary investigator on all critical laboratory related investigations.