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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 ...

Granules

EHS Manager (GMP experience required)

Chantilly, VA · On-site

$85K - $116K/yr

Investigate incidents, near-misses, and safety concerns; implement corrective and preventive actions (CAPA) * Oversee chemical safety, hazardous material handling, waste management, and emergency ...

Granules

Quality Control Manager

Chantilly, VA · On-site

Supervise lab processes, including timely management of investigations, CAPA implementation to ensure sustainable compliance * Review of SOPs, lab related investigations, stability failure ...

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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 is a CAPA manager?

A CAPA manager oversees the Corrective and Preventive Actions process within an organization to identify, investigate, and resolve quality issues or non-conformities. They ensure compliance with regulatory standards, often using quality management tools, and coordinate cross-functional teams to implement effective solutions.

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 job makes $10,000 a month without a degree?

A Capa Manager, or Corrective and Preventive Action Manager, can earn around $10,000 monthly by overseeing quality management systems in manufacturing or healthcare environments. Success in this role depends on experience, industry knowledge, and strong organizational skills, often without requiring a formal degree but emphasizing certifications and practical expertise.
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Capa Manager jobs near you
QC Manager

QC Manager

Precigen, Inc

Germantown, MD • On-site

$95K - $120K/yr

Full-time

Posted 25 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.