Quality Control Manager
Quality Control Manager
Posted on :
20-05-2025
Employer Active
1 Vacancy
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Job Description
Quality Control Manager
TheQuality Control Manager provides oversight for the safe and effective processing of pharmaceutical products manufactured at Niowave. The QC Manager will provide quality control oversight and direction from incoming material inspection and through product release. Projects and duties will be completed in compliance with applicable regulatory agencies standards.
As you embark into people management take note that these roles embrace leadership as a choice a responsibility and a remarkable privilege to positively impact the lives of others. Job satisfaction in People Management roles is measured by the synergy you instill in crossfunctional team members enabling them to achieve optimal outcomes. You model a positive learning environment and celebrate the journey as well as the destination.
Essential functions
- Review and approve documents in support of any quality control testing batch release testing and annual stability testing/data performed or generated.
- Hire manage train and develop QC personnel to ensure compliance with the applicable regulations.
- Provide onsite support during production runs/manufacturing of radioisotopes and final drug product.
- Ensure consistent application of microbiology methods and procedures for GMP laboratory testing.
- Prepare and provide monthly QC quality performance metrics to Senior Management.
- Maintain laboratory procedures in accordance with Good Laboratory/Manufacturing Practice standards.
- Participate and oversee internal and external audits as needed.
- Assist in the creation of Standard Operating Procedures protocols and reports.
- Develop and validate procedures within the department and comply with cGMP in all areas of the business.
- Initiate and approve nonconforming materials reports (NCMRs) investigate deviations laboratory outofspecification (OOS) and CAPA investigations. Perform risk assessments participate in root cause analysis investigations tracking followup and reporting/trending.
- Supervise environmental monitoring ofcontrolled spaces in accordance with all applicable standards.
- Serve as the subject matter expert in certain areas of Quality Control.
- Maintain and update laboratory databases to track and trend data.
- Provide onthefloor QC oversight of manufacturing operations.
- Perform other quality functions as necessary with appropriate training.
Team Management
- Leads and inspires a diverse team of skilled professionals.
- Establishes and maintains a technical direction and supervisory oversight structure for the department including career progression and succession planning.
- Hires fires promotes disciplines coaches and awards staff members according to organizational policies.
- Within the department and across the organization fosters a culture of respect safety quality and continuous improvement aligning with the mission vision and values of the organization.
- Holds consistent coaching sessions through 1:1s and career development meetings.
Competencies:
- Analytical and problemsolving skills with the ability to critically interpret and use data to manage risk.
- Excellent interpersonal written and oral communication skills.
- Organizational and project management skills for self and teams.
- Ability to manage multiple priorities simultaneously while meeting deadlines.
- Proven ability to lead and develop staff and teams.
- Expertly performs in a teamoriented collaborative environment.
- Embraces and models the Niowave Values of Teamwork Courage Integrity and Upright Zeal.
- Understands how to integrate into a new team/organization appreciates the history of current state know how and when to make suggestions as well as using just the right pace to reach the improved future state.
- Understands your own communication and learning styles can assess others styles and is able to find the right path to connect the two.
- Strong understanding and experience in Quality Systems and their successful implementation; Substantive knowledge of applicable GMP and related pharmaceutical manufacturing regulations.
- Strong technical ability to work collaborate and negotiate with government officials consultants and other thirdparty stakeholders.
- Develops and maintains good relationships gains the confidence of others and works effectively in a multidisciplinary matrix environment.
- Knowledge of 21 CFR Part 210/211.
Required Education and Experience
- Bachelors degree or equivalent in Science/Engineering or a related field.
- 8 years of experience in quality compliance manufacturing operations within a GMP pharmaceutical or radioisotope manufacturing setting.
- 5 years experience managing daytoday activities of five or more team members with demonstrated ability to build cohesive teams establish career development tracks and succession planning.
- Experience operating in a cGMP CDMO or Finished Drug environment with ability to apply best practices in GXP.
- Experience with Quality Control processes and procedures.
- Handson experience utilizing root cause tools and lean manufacturing principles for continuous improvements (Six Sigma Lean Manufacturing 5S pareto correlation and regression analysis DOE SPC trend analysis flow charts 5Why Fish Bone A3)
Preferred Education and Experience
- Masters degree in science/engineering field or equivalent experience
- 10 years of Quality Assurance experience operating in a cGMP manufacturing environment.
- Experience with radioactive material.
- Experience with Minitab JMP or other analytical tools.
- Previous medium to large scale project management experience.
- Knowledge of 21 CFR Part 212 and ICH Q7Q12 Nuclear Regulatory Commission (NRC) regulations or similar regulatory compliance experience.
Physical Demands
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- The position operates in a professional office and industrial environments which includes the use of standard office equipment and/or machinery related to the production of medical isotopes.
- While performing the duties of this job the employee is occasionally required to:
- use hands to finger handle or feel objects tools or controls; reach with hands and arms; wear safety glasses googles gloves lab coat and/or Tyvek suit
- talk and hear; climb stairs; walk throughout all locations of the company
- occasionally lift or move office products and supplies up to 25 pounds
- may stand and sit for prolonged periods.
Position Type/Expected Hours of Work
- Fulltime position.
- Companys standard operating hours are Monday thru Friday 6a 6p with production related activities requiring 24/7/365 shifts.
- This position will have regular working hours during M F with an expectation of adjusting to work outside of the standard operating hours as needed.
- Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role.
Other duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities duties or responsibilities that are required of the employee for this job. Duties responsibilities and activities may change at any time with or without notice.
Required Experience:
Manager
Employment Type
Full Time
Key Skills
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