Quality Assurance Operations Manager

1 day ago

Morrisville, NC, United States Boston Analytical Full time

JOB SUMMARY

The Quality Assurance Operations Manager supports the Director of Quality Assurance to ensure compliance to regulations and internal procedures while meeting company goals and client requirements. The QA Operations staff reviews all data prior to release and is responsible for the quality review of associated systems (e.g. OOS investigations, SOPs, validation protocols/reports).

PRIMARY DUTIES AND RESPONSIBILITIES

  • Provide direct oversight to QA operations staff.
  • Supervise direct report(s) which includes setting objectives, monitoring performance and conducting reviews.
  • Review, approve Laboratory test data and reports.
  • Prepare and approve certificates of Analysis.
  • Support activities related to internal and external audits.
  • Represent site Quality group during Client and regulatory audits.
  • Collaborate with Laboratory management to support company goals.
  • Works directly with laboratory operations, and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner.
  • Creates and reports metrics for quality system key performance indicators and provides quality and compliance assessments to senior management as required and contribute to strategic direction or initiatives to achieve organizational effectiveness.
  • Actively participate in operational excellence programs/initiatives.
  • Review laboratory protocols and reports for accuracy and compliance to cGMP's, as applicable.
  • Site system owner for OOS, complaint, and deviation programs.
  • Review and approval of validation plans, deviations, failure investigations and corrective action plans prior to implementation.
  • Completes required actions for identified corrective/preventive actions for the Quality department.
REQUIREMENTS & QUALIFICATIONS

Qualification include a Bachelor's degree in a related discipline with 6+ years of QA/QC experience in the pharmaceutical industry and 2+ years of mentoring and supervising direct reports. Strong familiarity with regulatory/compliance environment (cGMP, GLP) associated with biotechnological, parenteral drug manufacture and/or medical device production. Experience in root cause analysis, risk management, and corrective/preventative action development.

DESIRED SKILLS
  • Enthusiastic, team player, collaborative across all departments to achieve the common goals.
  • Ability to focus on internal processes while maintaining focus on client needs.
  • Ability to work in a fast paced, dynamic environment.
  • Experience with LEAN implementation.
  • Familiarity with laboratory information management systems.
  • ISO 17025 or 9001 experience and knowledge.
  • Demonstrated ability to foster a Quality Culture across the organization.
  • Team player with integrity and concern for the quality of Company products, services and staff members. Ability to be an effective hands-on leader.

  • Quality Assurance

    2 weeks ago

    Morrisville, NC, United States Adecco Full time

    Adecco is hiring immediately for a Quality Assurance with a local client in Morrisville, NC! Apply now if you meet the qualifications listed below! Contract Type: Temporary Pay: $18.00 per hour Shift/Hours: Day Shift, 7:00 AM - 7:00 PM Essential Duties: Conduct talent assessments and facilitate training sessions using various methods (coaching, workshops,...

  • Quality Assurance

    2 weeks ago

    Morrisville, NC, United States Adecco Full time

    Adecco is hiring immediately for a Quality Assurance with a local client in Morrisville, NC! Apply now if you meet the qualifications listed below! Contract Type: Temporary Pay: $18.00 per hour Shift/Hours: Day Shift, 7:00 AM - 7:00 PM Essential Duties: Conduct talent assessments and facilitate training sessions using various methods (coaching, workshops,...

  • Sr. Quality Assurance Specialist

    3 days ago

    Morrisville, NC, United States Alcami Corporation Full time

    Sr. Quality Assurance Specialist - 2nd shiftLocation US-NC-MorrisvilleID 2025-1743Category Quality AssurancePosition Type Full-TimeWorking Hours 2nd Shift: Monday - Friday, 2:30pm - 11:30pmAt Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with...

  • Quality Assurance

    1 week ago

    Morrisville, NC, United States Adecco US, Inc. Full time

    Adecco is hiring immediately for a Quality Assurance with a local client in Morrisville, NC! Apply now if you meet the qualifications listed below! Contract Type: Temporary Pay: $18.00 per hour Shift/Hours: Day Shift, 7:00 AM - 7:00 PM Essential Duties: Conduct talent assessments and facilitate training sessions using various methods (coaching,...

  • Quality Assurance

    7 days ago

    Morrisville, NC, United States Adecco US, Inc. Full time

    Adecco is hiring immediately for a Quality Assurance with a local client in Morrisville, NC! Apply now if you meet the qualifications listed below! Contract Type: Temporary Pay: $18.00 per hour Shift/Hours: Day Shift, 7:00 AM - 7:00 PM Essential Duties: Conduct talent assessments and facilitate training sessions using various methods (coaching,...

  • Quality Assurance

    2 weeks ago

    Morrisville, NC, United States Adecco US, Inc. Full time

    Adecco is hiring immediately for a Quality Assurance with a local client in Morrisville, NC! Apply now if you meet the qualifications listed below! Contract Type: Temporary Pay: $18.00 per hour Shift/Hours: Day Shift, 7:00 AM - 7:00 PM Essential Duties: Conduct talent assessments and facilitate training sessions using various methods (coaching,...

  • Sr. Quality Assurance Specialist, GMP Manufacturing

    2 weeks ago

    Morrisville, NC, United States Alcami Corporation Full time

    Sr. Quality Assurance Specialist, GMP Manufacturing - 3rd ShiftLocation US-NC-MorrisvilleID 2025-1673Category Quality AssurancePosition Type Full-TimeWorking Hours 3rd Shift: Sunday - Thursday, 11:00pm - 8:00amAt Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through...

  • Associate Director, Laboratory Quality Operations

    3 days ago

    Morrisville, NC, United States Alcami Corporation Full time

    At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Associate Director, Laboratory Quality Operations is...

  • Associate Director, Laboratory Quality Operations

    1 week ago

    Morrisville, NC, United States Alcami Corporation Full time

    At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary The Associate Director, Laboratory Quality Operations is...

  • Manager-Quality Performance

    2 days ago

    Morrisville, NC, United States Alliance Full time

    Under the general guidance of the Quality Management Director, the Manager of Quality Performance plays a central role in continuously improving Alliance’s quality related strategies and innovation capabilities. The candidate must be a proven people developer with a collaborative approach that builds trust within internal and external stakeholders...