Manager, Quality Assurance Investigations
Company: Contract Pharmacal Corp
Posted on: May 12, 2022
Manager, Quality Assurance Investigations
Hauppauge, NY --- QA Compliance
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
Responsibilities: Responsibilities include, but are not limited
- Manage the QA Investigations department to ensure that all
related quality events are completed in a compliant and timely
- 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
- Lead continuous improvement projects in the QA Compliance and
associated sub-departments with specific focus on the QA
- 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
Education and Experience:
- Bachelor's degree in Chemistry, Biology, Engineering or related
- Master's degree in Chemistry, Biology, Engineering or related
- 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
Skills and Abilities:
- Knowledge of cGMPs related to US FDA and EU EMEA manufacturing
- Knowledge of Quality Management System requirements
- Knowledge of ICH, USP, and EP requirements
- Proficiency in Microsoft Word, Excel, graphs/charts and
- 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
- Prepare and manage assigned work for team members
- 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
- 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
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