QC Lab Investigation Specialist

Title: QC Lab Investigation Specialist

Company: Pharmaceutical / Biotech

Location: New York – Amityville

Type: Permanent Role

Notes: No Corp to Corp

Company Overview

Specializes in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays.

Essential Functions:

Reviews, coordinates, and assists to ensure non-conformances are adequately investigated for determination of root cause and product impact per FDA regulations. Using Root Cause analysis training, manage and coordinate quality control laboratory investigations (out-of-specification, out-of-trend, non-conformance, and deviation). Ensures corrective and preventive actions (CAPA) are identified and implemented to prevent/reduce reoccurrence.

Essential Functions:

• Author, track monitor, facilitate closure, and QA review of investigations, out of specification (OOS) and out of trend (OOT) reports for compliance to FDA regulations and other guides/guidelines.
• Using root cause determination techniques, perform Non-Conformance, Deviation, OOS, and OOT investigations to determine the root cause and effective corrective / preventive action (CAPA) implementation to prevent recurrence of the event.
• Experience performing, reviewing and issues associated with Quality Control laboratory chemical and physical testing.
• Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines.
• Provide cGMP guidance to functional groups such that all non-conformances are closed within defined timeframes and product release dates.
• Work with cross-functional teams to develop and track CAPA plans.
• Work with quality control and operations personnel in performance of effective investigations.
• Evaluate trends of investigations and CAPA’s to identify major areas of opportunity for improvement.
• Assist during regulatory inspections or other audits as required
• Provide training to function areas on compliance issues
• Other duties as required

Additional Responsibilities:

• Ability to work effectively as a team and independently.
• Proficient at Microsoft Outlook, Excel, and Word.
• Strong communication skills and presentation skills
• Ability to abide by quality standards.

Requirements:

• Bachelor of Science in Chemistry or equivalent experience. 2 years of root cause analysis experience related to quality control non-conformances, preferably pharmaceutical of FDA regulated laboratory and prior knowledge of Track Wise system is a plus.
• Minimum of 5 years’ experience in Quality Systems relating to deviations, investigations, out of specifications (OOS), non-lab out of specifications, corrective and preventive actions (CAPA), and product complaints.
• In addition, experience in performing cGMP related training preferred
• Ability to apply deductive reasoning and understand complicated issues.
• Ability to receive instructions and follow work rules and company policies.
• Ability to follow safety and security practices.
• Ability to meet deadlines and effectively deal with office stress.
• Must exhibit strong organizational, communication, interpersonal skills and attention to detail.
• Ability to accurately communicate ideas, facts, and technical information.
• Maintain confidentiality of certain information.

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