Manager, Quality Assurance Investigations

Company: Contract Pharmacal Corp
Location: Hauppauge
Posted on: May 12, 2022

Job Description:

Manager, Quality Assurance Investigations
Hauppauge, NY --- QA Compliance
Description

Position Summary:
The Quality Assurance (QA) Investigations Manager has primary responsibility for managing and overseeing quality events investigation, corrective and preventative actions, and related technical activities at CPC. This includes researching, investigating and developing continuous improvement solutions in regard to compliance in areas related to manufacturing, packaging and warehousing. Quality events scope will include deviations, product complaints, CAPAs, NCR's, rework/reprocessing protocols etc.
Responsibilities: Responsibilities include, but are not limited to:
- Manage the QA Investigations department to ensure that all related quality events are completed in a compliant and timely manner.
- Ensure that the QA Investigations department effectively coordinate cross-functional teams to conduct comprehensive investigations to determine product impact, identify root cause and implement corrective and preventative actions.
- Lead the training and development of QA Investigations personnel to improve their skills and proficiencies in quality events investigations and root cause analysis.
- Conduct investigations and develop investigation reports for Deviations, Product Complaints, NCRs, etc.
- Review investigation reports and ensure the reports are written with clear, concise information with appropriate details.
- Develop and review rework/reprocess protocols
- Coordinate and implement CAPA and assess CAPA effectiveness
- Maintain quality department metrics
- Track trends of quality events such as Deviations, Product Complaints and NCRs, and suggest proper CAPAs for continuous improvement
- Lead continuous improvement projects in the QA Compliance and associated sub-departments with specific focus on the QA Investigations department.
- Strictly follow all applicable safety and standards guidelines, such as SOP, cGMP, DEA regulations and/or SDS
- Perform internal audits to ensure compliance with departmental SOPs, logbook completion, housekeeping, etc.
- Support QA Compliance department functions including, vendor audits, quality agreements, annual product review, computer validated system administration, QA metrology, DEA activities, Food Defense Plan, PPPA/Container Closure, facilities and regulatory licensing, product certifications etc.
- Other responsibilities as assigned by Senior Management
Requirements

Education and Experience:
- Bachelor's degree in Chemistry, Biology, Engineering or related discipline required
- Master's degree in Chemistry, Biology, Engineering or related discipline preferred
- At least 5 years' experience with pharmaceutical company serving quality and/or investigation role with 2 years of managerial / supervisory experience required.
- Experience with Six Sigma, Lean, Practical Process Improvement preferred

Skills and Abilities:
- Knowledge of cGMPs related to US FDA and EU EMEA manufacturing environments
- Knowledge of Quality Management System requirements
- Knowledge of ICH, USP, and EP requirements
- Proficiency in Microsoft Word, Excel, graphs/charts and databases
- Ability to communicate effectively, compile, manage and interpret data, strong technical writing skills
- Strong data analysis skills and proficient in related data analysist techniques and computer programs
Supervisory Responsibilities:
- Prepare and manage assigned work for team members
Work Environment:
- Required to be present in the office to collaborate with peers and supervisors on an as needed basis
- Potential to move between office sites/areas, including stairs, to complete job functions
- Work/Travel schedule must be adhered to and/or changed as needed to meet business requirements.
- Employee work hours/schedule and/or shift are subject to change based on business needs and Management discretion.
- Responsible for compliance with all rules and regulations pertaining to safety helping to ensure that all department operations are performed with the utmost regard for the safety and health for all personnel
Physical Demands:
- Required to sit and stand for long periods of time.
- Occasionally required to walk and kneel.
- Must be able to lift and/or move up to 50 pounds
- Must be able to use close vision, distance vision, peripheral vision, color vision and the ability to adjust focus.
- Required to reach with arms and use hands and fingers to handle or feel objects and tools
- Required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs and ladders
Personnel Protective Equipment or Attire Required for Position:
- As needed

Keywords: Contract Pharmacal Corp, Stamford , Manager, Quality Assurance Investigations, Executive , Hauppauge, Connecticut