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Capa Manager Jobs in Washington (NOW HIRING)

Granules

Quality Assurance Manager

Manassas, VA · On-site

... CAPA's (including verification of CAPA's) and other quality documents as needed. * Manage and ... maintain audit inspections (Internal and External) for the site. * Responsible for supporting the ...

VB Spine

Associate Manager, R&D

Leesburg, VA · On-site

$125K - $135K/yr

Mentor others on industry standards, design requirements, test strategies, design controls, risk management, and NC/CAPA processes * Identify and implement improvements to reduce cost, increase ...

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Capa Manager information

What does a CAPA manager do?

A CAPA (Corrective and Preventive Action) Manager is responsible for overseeing an organization's CAPA process to ensure compliance with quality and regulatory requirements. They investigate quality issues, identify root causes, and implement corrective and preventive measures to prevent recurrence. CAPA Managers work closely with cross-functional teams to improve processes, maintain regulatory compliance, and enhance overall product or service quality.

What are some common challenges a CAPA manager faces, and how are they typically addressed?

One common challenge CAPA Managers face is ensuring timely and thorough investigations into quality issues while coordinating input from multiple departments. Balancing the need for fast resolution with the rigor required for regulatory compliance can be demanding, especially in highly regulated industries like pharmaceuticals or medical devices. Successful CAPA Managers often address these challenges through clear process documentation, effective project management, and fostering strong collaboration among stakeholders. By leveraging root cause analysis tools and maintaining open communication, they help create a continuous improvement culture that benefits both the organization and its customers.

What are the key skills and qualifications needed to thrive as a CAPA manager?

To thrive as a CAPA Manager (Corrective and Preventive Action Manager), you typically need a background in quality assurance, strong analytical and problem-solving abilities, and experience with regulatory compliance, often supported by a degree in a science or engineering field. Familiarity with quality management systems (QMS), risk management tools, root cause analysis methodologies (such as 5 Whys or Fishbone diagrams), and industry certifications like Six Sigma or ISO 9001 are highly valued. Outstanding candidates demonstrate excellent communication, leadership, and organizational skills to effectively drive cross-functional teams and ensure timely resolution of quality issues. These skills are crucial for identifying, addressing, and preventing compliance gaps or product issues, thereby maintaining high standards and avoiding costly regulatory penalties.

What are popular job titles related to Capa Manager jobs in Washington? For Capa Manager jobs in Washington, the most frequently searched job titles are:
What job categories do people searching Capa Manager jobs in Washington look for? The top searched job categories for Capa Manager jobs in Washington are:
What cities in Washington are hiring for Capa Manager jobs? Cities in Washington with the most Capa Manager job openings:
Capa Manager jobs near you

Quality Assurance Manager

GRANULES CONSUMER HEALTH LLC

Manassas, VA • On-site

Full-time

Re-posted 17 days ago

Job description

Description

*This is an Onsite Role**


The QA Manager ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing documentation for all quality system functions in accordance with cGMP and related company SOP's, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.

  • The person will be responsible for managing and ensuring that facility meets all GMP, FDA and SOP requirements.
  • Managing all quality operations to include inspection of components, bulk, and final products for the Manassas, VA, ensuring release lead times are met with timely product disposition.
  • Ensure that the facility is meeting all training requirements.
  • Lead the communication of open quality document notification and resolution between all departments regarding Complaints, Investigations, Change Control, CAPA's (including verification of CAPA's) and other quality documents as needed.
  • Manage and maintain audit inspections (Internal and External) for the site.
  • Responsible for supporting the preparation, review, processing, and approval of various validation documents as application for the Granules, Manassas, facility.
  • Provide QA support, review and approval for relevant documents including relevant procedures, batch records, specifications, stability reports, technical reports (i.e., Qualification, Validation, Transportation.), trend reports, Annual Product Quality Reviews and other documents as needed.
  • Responsible for performance and development of all Quality Assurance staff through mentoring and focusing on personal and professional growth.
  • Work with Quality leadership team for proactive succession planning and a high-performance culture through people.
  • Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year.
  • Provide the means for incorporating the necessary tools, equipment, and methods into the new and existing processes aimed at continuous improvement.
  • Implementation Quality management system tools and their compliance.
  • Development and execution of quality training modules for the organization.
  • Ensure staff receives appropriate knowledge and skill development and growth opportunities
  • Work with Regulatory Affairs to supply information needed for FDA filings.
  • Other duties as assigned by management.

 


Requirements

Knowledge & Skills


Expert-level knowledge of the FDA guidance for Industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc...)

cGMP compliance within the pharmaceutical manufacturing industry.

Writing and maintaining cGMP documentation.

Analyze data/information and resolve complex issues.

Verbal and written communication skills.

Work and communicate with cross-functional teams.

Multiple priorities and re-prioritize tasks.

Strong computer skills and working knowledge of Microsoft Office Suite and Adobe

Demonstrated ability to work on complex assignments in collaboration with various departments.


Experience & Education


Bachelor's degree in the life sciences (or equivalent work experience) minimum of 6+ years in a QA role within the pharmaceutical industry

Master's degree with 4+ years of pharmaceutical manufacturing experience and at least 3 years of those years in a progressive challenging QA department in the pharmaceutical industry.


Physical Requirements/Working Environment


While performing the duties of this job, the employee is regularly required to, stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard.

Specific vision abilities required by this job include close vision requirements due to computer work.

Ability to sit at a computer terminal for an extended period of time.

Light to moderate lifting up to 10-15 lbs is required.

Ability to work in a confined area

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