drjobs Director of Quality Control

Director of Quality Control

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1 Vacancy
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Job Location drjobs

Hunt Valley, MD - USA

Monthly Salary drjobs

$ 103100 - 185600

Vacancy

1 Vacancy

Job Description

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the worlds top brands offering comprehensive engineering manufacturing and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

Job Overview:

Overall responsibility for the Quality Control function daily.

Responsibilities:

  • Direct and supervise personnel and activities within the Quality Control Laboratory
  • Develop strategic plans for the Department and personnel.
  • Execute assignments as directed by the Head of Quality with no supervision.
  • Independently manage all laboratory activities for assigned functions and projects. This includes developing timelines daily (and longer-term) work plans assignments and milestones for their direct reports.
  • Manage motivate develop and coach members of the QC Laboratory to achieve identified objectives maximize their potential and continuously improve their individual effectiveness in meeting business needs.
  • In support of other Departments (e.g. QA RA) execute investigations deficiency-letter responses and CAPA-related activities.
  • Interface with Analytical R&D Quality Assurance Business Development and Manufacturing Departments for coordination of project activities.
  • Support formulation development and transfer activities for assigned projects.
  • Investigate method performance reliability and improvement issues and evaluates proposed changes to compendia! or in-house methods.
  • Prepare and review technical documents including validation protocols and reports reference standard qualification reports analytical test procedures Certificates of Analysis; technical reports change controls and writes investigations and deficiency reports.
  • Provide training technical expertise and support to the laboratory staff.
  • Standardize processes throughout the laboratory. Enforces compliance to cGMPs and SOPs.
  • Ensure that the analytical procedures developed reviewed or established in the laboratory conform to current and appropriate scientific and regulatory standards are suitable for use for their intended purpose.
  • Develop and implement procedures systems and training activities to develop an appropriate level of scientific expertise within the laboratory to ensure the successful execution of project.
  • Work to current pharmaceutical-industry technical standards and to maintain compliance with cGMPs.
  • Audit and review laboratory data generated by their groups.
  • Recommend the need for new equipment to serve expanding operational and regulatory requirements.
  • Ensure that specific objectives and goals of the department are met.
  • Oversee and ensure that all laboratory equipment qualifications calibrations and preventative maintenance programs are maintained.
  • Collaborate with colleagues in Research & Development Regulatory Affairs Quality Assurance and external partners and vendors or contractors to achieve Project goals Supports formulation development and transfer activities for assigned projects and for the filing of new products.
  • Perform other duties as assigned.

Qualifications:

  • Bachelors degree or equivalent combination of education training and professional experience that provides the individual with the required knowledge skills and abilities.
  • I0 years of experience in analytical organic or pharmaceutical chemistry within the discipline of analytical chemistry and quality control in the pharmaceutical industry
  • Current understanding of state-of-the-art analytical instrumentation and equipment.
  • Must be familiar with the operation and maintenance of the various pieces of analytical equipment and instruments used in the laboratory.
  • Strong problem-solving ability. Leads investigations and recommends corrective actions.
  • Ability to mentor and provide best practices to new technicians.
  • Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.
  • Strong experience with project and people management.
  • Able to administer personnel performance evaluations.
  • Demonstrate the ability to write and understand technical information and produce detailed reports.
  • Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments including vendors colleagues and subordinates.
  • Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
  • Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
  • Must be able to comprehend and follow all applicable SOPs.
  • Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
  • Demonstrate solid understanding on the current federal local and international regulations regarding the production testing and release of drug substances and products.
  • Good understanding of cGMPs industry and regulatory standards and guidelines.
  • Demonstrate familiarity with Microsoft programs like Word Excel PowerPoint Project Teams Outlook etc.
  • Demonstrate the ability to portray the appropriate level of integrity and professionalism.
  • Demonstrate the ability to communicate effectively with management staff regulators and client representatives in written and verbal formats.
  • Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
  • Demonstrate the ability to make quality scheduling resource allocation and priorities decisions.
  • Energetic execution-focused self-motivated and organized individual who is accustomed to working in a deadline-focused high-pressure entrepreneurial environment.
  • Results-oriented and efficient.
  • Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
  • Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
  • Demonstrate the ability to work well in a cross-functional team environment.
  • Must communicate fluently in English and have legible handwriting.

Physical Demands:

  • Ability to travel between and within facilities to visit staff operations and projects as needed.
  • Ability to sit stand climb stairs and climb ladders to mezzanines (when necessary).
  • Ability to lift up to 40 pounds on occasion.
  • Ability to use PPE (safety shoes goggles respirators gloves etc. when necessary).

The pay range for this role is $103100 - $185600. Job-related non-discriminatory factors used to determine the actual offered rate include qualifications and experience geographic location education external market data and consideration of internal equity.

As part of the total rewards package Jabil offers benefits to enhance your health wealth and resilient self. These include medical dental and vision insurance plans; paid time off; paid parental leave; company-paid holidays subject to change yearly;401(k) retirement plan; and employee stock purchase plan.

BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number birth certificate financial institution drivers license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft contact the Federal Bureau of Investigations internet crime hotline () the Federal Trade Commission identity theft hotline () and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.

Jabil including its subsidiaries is an equal opportunity employer and considers qualified applicants for employment without regard to race color religion national origin sex sexual orientation gender identity age disability genetic information veteran status or any other characteristic protected by law.

Accessibility Accommodation

If you are a qualified individual with a disability you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to or calling with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail or phone number. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.

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Required Experience:

Director

Employment Type

Full-Time

Company Industry

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