ZipRecruiter

Log In

1

Capa Manager Jobs in Washington (NOW HIRING)

Precigen, Inc

QC Manager

Germantown, MD · On-site

$95K - $120K/yr

Job Title: QC Manager Department: Quality Control - Analytical GENERAL DESCRIPTION: * QC Manger is ... Write deviations, CAPA's and own change controls. * Review/Provide guidance for deviations/CAPA ...

Avint

QA/QC Manager

Washington, DC · On-site

$150K - $160K/yr

Initiate and oversee Corrective and Preventive Actions (CAPA) * Establish and execute 3-Phase Quality Control Program (Preparatory, Initial, Follow-up) * Conduct and manage inspections, audits, and ...

Avint

QA/QC Manager

Washington, DC · On-site

$150K - $160K/yr

Initiate and oversee Corrective and Preventive Actions (CAPA) * Establish and execute 3-Phase Quality Control Program (Preparatory, Initial, Follow-up) * Conduct and manage inspections, audits, and ...

next page

Showing results 1-20

All JobsCapa JobsCapa Manager JobsCapa Manager Jobs in Washington

Capa Manager information

What is the role of a Capa specialist?

A CAPA (Corrective and Preventive Action) specialist is responsible for investigating quality issues, implementing corrective actions, and preventing recurrence of problems within a quality management system. They analyze data, ensure compliance with regulations, and often use tools like root cause analysis to improve product and process quality.

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 is a capa coordinator?

A CAPA (Corrective and Preventive Action) coordinator is responsible for managing and overseeing the CAPA process within a quality management system. They investigate quality issues, implement corrective actions, and ensure compliance with regulatory standards, often using tools like root cause analysis and tracking software. This role requires strong organizational skills and knowledge of quality regulations such as ISO or FDA requirements.

What is the highest paying manager position?

The highest paying manager positions are typically executive roles such as Chief Executive Officer (CEO), Chief Operating Officer (COO), and Chief Financial Officer (CFO), which often have salaries exceeding several hundred thousand dollars annually. In some industries, specialized managerial roles like Vice President or Director of certain departments can also command high compensation, especially with bonuses and stock options included.

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 in the Capa Manager position, and why are they important?

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 does a capa manager do?

A CAPA (Corrective and Preventive Action) manager oversees the implementation of processes to identify, investigate, and resolve quality issues within an organization. They analyze root causes, develop action plans, and ensure compliance with regulatory standards, often using quality management systems and tools like CAPA software. The role requires strong problem-solving skills and knowledge of industry regulations such as ISO or FDA standards.
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
QC Manager

QC Manager

Precigen, Inc

Germantown, MD • On-site

$95K - $120K/yr

Full-time

Posted 29 days ago

Job description

Job Title: QC Manager

Department: Quality Control - Analytical

GENERAL DESCRIPTION:

  • QC Manger is responsible for overseeing a team of QC Analysts and is also responsible for maintaining the QC Laboratory in a state of cGMP compliance.

    DUTIES AND RESPONSIBILITIES:
  • Training, coaching, and development of QC staff
  • Develop, revise, and review SOPs, qualification/validation protocols and reports.
  • Write deviations, CAPA’s and own change controls.
  • Review/Provide guidance for deviations/CAPA’s generated by QC Analysts
  • Responsible for reviewing invalid assays and lead invalid assay investigations
  • Participating in OOS investigations
  • Responsible for ensuring all analytical data generated by QC lab to be initiated on time and completed within established TAT’s.
  • Perform review of QC documentation (equipment logbooks, sol’n prep record, cell line records, TRF’s, etc)
  • Ensure test results are entered into the appropriate reports
  • Track/Trend Ref. Std, Assay Control and Critical Reagents
  • Track equipment cleaning/PM/Calibration schedules
  • Review equipment IOQ’s and Re-Qualifications
  • QC Process/Procedure continuous improvements
  • Perform other duties as needed

EDUCATION AND EXPERIENCE:

  • BS degree in the Biological Sciences, Bioengineering, or Chemistry.
  • 7+ years of experience performing QC activities in the pharmaceutical and biotech industry under GMP guidelines, with demonstrated expertise in multiple disciplines and assays.
  • 2+ years of supervisory experience.
  • Advanced experience with QC testing in pharmaceutical or biopharmaceutical laboratories
  • Familiarity with analytical testing procedures: qPCR, HPLC, ELISA, Cell-based Assays, etc.


DESIRED KEY COMPETENCIES:

  • Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data
  • Ability to provide support for regulatory and client audits, as well as interact with clients.
  • Ability to effectively negotiate and build collaboration amongst individuals.
  • Ability to be self-motivated, proactive, accountable, and flexible
  • Demonstrate the ability to develop, coach and mentor key employees.
  • Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
  • High attention to detail, highly organized, and excellent documentation skills
  • Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on upon changing priorities.