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Available Positions

Available Positions

MANAGER TECHNICAL QUALITY OPERATIONS(Corporate Office)

NATURE AND SCOPE:

Review and approval of technical documentation, including but not

limited to; Deviations, Complaint Investigations, and CAPA; APR Summary Reports; Internal

and External Audit Reports; Technology Transfer protocols and reports; Stability protocols

and reports; and Validation and Qualification Protocols and Reports.

 

RESPONSIBILITIES:

  • Manage and assign TQO staff in assessing and facilitating the resolution

    of deviation and complaint investigations as necessary. This includes the identification and follow-up of CAPA.

  • Manage and assign TQO staff in review and approval of tech transfer documentation, R&D protocols and reports, validation and qualification protocols and reports, and change control justifications.

  • Manage and assign TQO staff in the scheduling, performance, and reporting of internal and external (i.e. Contract Manufacturers, APIs, Excipients, Container Closure, Testing

    Laboratories, and others as necessary) quality audits. Reviews and approves audit reports and recommend corrective actions, if necessary, and the verification of corrective actions.

  • Manage the Annual Product Review process

  • Manage TQO staff for the initiation and implementation of technical projects, as necessary.

  • Act as a Liaison between QA and other departments on technical issues and report back to the Director of QA.

  • Identify quality process improvements to increase efficiencies and performance of

    systems, operations and personnel.

  • Identify and resolve objectionable cGMP issues which may impact quality and reports to

    senior management.

  • Ensure all work is performed and documented in accordance with existing Company

    policies and procedures, as well as cGMP and health and safety requirements in the

    markets where product is sold.

QUALIFICATIONS:

  • Bachelors’ degree in Science related field.

  • 5+ years in a pharmaceutical setting with at 3 years management experience.

  • Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP)

    requirements and guidelines and documentation practices.

  • Strong technical writing skills.

  • Ability to lead cross functional teams.

 

SENIOR MANAGER ENGINEERING (Corporate Office)

NATURE AND SCOPE:

This position directly manages engineering and maintenance of three facilities, all utilities, and manufacturing equipment in an FDA regulated environment. Excellent managerial, communication, and technical skills are necessary to support current and future operations.

 

RESPONSIBILITIES:

  • Plan, direct and coordinate all engineering functions for facilities, utilities and manufacturing operations activities.

  • Prepare all capital budgets, manage annual capital budgets and prepare capital expense forecast updates.

  • Conduct facility space planning, allocation, and development of additional space as required, perform cost analysis, and research facility alternatives.

  • Review projects, develop RFP’s, conduct bidding, review quotes and oversee installations.

  • Establish work plans and staffing for each phase of project and review status on an ongoing basis.

  • Oversee security for Luitpold and all security systems for all buildings.

    Oversee housekeeping of all buildings.

  • Ensure 24 hour support and emergency response for all critical building systems, ensure reliability of all equipment and utility support systems, ensure adequate training of all mechanics, co-ordinate with all utilities/Local Fire Department/Police during any emergency.

QUALIFICATIONS:

  • Bachelor’s of Science in Engineering required, MBA preferred

  • Minimum of 5 years project engineering experience

  • Possess a strong working knowledge of mechanical, electrical, HVAC, water, fire suppression and structural systems.

  • Have a strong working knowledge of the construction process.

  • Exercise excellent managerial skills with a proven track record.

  • Use strong oral and written communication skills in the preparation and delivery of presentations.

  • Proficient in AutoCAD, MS Office and Outlook.

  • Possess knowledge of telecommunications and modern security systems.

     

PROJECT MANAGER (Corporate Office)

RESPONSIBILITIES:

  • Responsible for all aspects of project management for Quality Assurance, Quality Control and Manufacturing.
  • Possess a clear understanding of the QA, QC and manufacturing process in the pharmaceutical industry.
  • Facilitate problem-solving and decision making with respect to project deliverables and meeting timelines.
  • Monitor project budgets to provide updates to the Executive Management Team with needed.
  • Provide input on project team member performance to aid the functional heads in employee performance evaluations.
  • Fully understand business cases including all internal and external factors which may derail the project and alert senior management of any potential pitfalls.
  • Communicate all pre-defined events to team members and other stakeholders according to communication plan. Monitor and communicate any changes in project scope, timeline and cost to all appropriate individuals.

QUALIFICATIONS:

  • Bachelors Degree in Business or Science, MS or MBA preferred.
  • 3 years project management experience in pharmaceutical environment.
  • Exceptional influencing and team development skills.
  • Superior organizational skills, must be able to manage multiple projects with high priority.
  • Effective communication skills, both verbal and written.
  • Solid presentation skills.
  • Proficient in Project Management Software.

 

QA INSPECTOR (Corporate Office)

RESPONSIBILITIES:

  • Performs inspection functions as assigned by the QA Supervisor, including but not limited to;

  • incoming inspection, in-process inspection, and final inspection

  • Performs visual inspection of Reserve units at specified intervals.

  • Performs reviews of batch documentation at appropriate stages of manufacture and releases batches to the next stage.

  • Performs special projects associated with inspection, which may include collecting data from previous inspections, and generating reports for management.

  • Overseas day to day manufacturing operations and reports any cGMP compliance issues to the asst. Supervisor/Supervisor.

 

QUALIFICATIONS:

  • Requires a high school diploma or its equivalent and 1-2 years of experience in the field or in a related area.

  • Has knowledge of commonly-used concepts, practices, and procedures within the field.  

 

 

TRACKWISE ADMINISTRATOR (Corporate Office)

RESPONSIBILITIES:

  • Manages the project plan, including tracking against all major milestones and deliverables.
  • Communicates with project stakeholders throughout the project life cycle.
  • Coordinates meetings and schedules necessary resources throughout the project life cycle.
  • Escalates issues through Sparta or the Company, as appropriate.
  • Evaluates risks and defines risk mitigation plan.
  • Reviews validation documentation, as needed by the CSV team.
  • Reviews documents written by Sparta, as applicable.
  • Participates in all aspects of the project, from requirements gathering to Go-Live and Support.
  • Assists in business process definition and TrackWise requirements gathering.
  • Maintains regular contact with Sparta and participates hands-on in configuration activities.
  • Manages the User Acceptance Testing of Workflow Activities for the End User Team.
  • Learns the system in order to conduct Go-Live support and assists in end-user training.
  • Assists in the functional testing of the system.
  • Primary TrackWise system contact with Sparta Support Services.
  • Training of end users for their specific workflow processes.
  • Drive requested form/workflow/report modifications using a risk based approach to determine validation/regression testing requirements.
  • Day to day troubleshooting and end user assistance requests.

QUALIFICATIONS:

  • Bachelor’s Degree in Computer Science or equivalent.
  • 3 years Trackwise Systems Administration experience in pharmaceutical environment.
  • Exceptional influencing and team development skills.
  • Superior organizational skills, must be able to multi task system related items with high priority.
  • Effective communication skills, both verbal and written.
  • Solid presentation skills.
  • The TrackWise Administrator must have experience with the Microsoft office suite: Word, Access, Excel, Visio, PowerPoint and Project.
  • Crystal Reports development experience.

 

 

MANAGER OF QUALITY ASSURANCE, DEVICE PRODUCTS (Corporate Office)

RESPONSIBILITIES:

  • Provide regulatory and device development guidance and assist in the creation, implementation, maintenance and adherence to the Quality Systems required for the development, manufacture and release of medical devices.

  • Responsible for inspection of incoming device products / components and documentation activities including, but not limited to: Incoming, In-Process, and Final Inspection; Change Control, Deviations/CAPA’s, complaints, SOP’ss, Monographs, Batch Record Issuance, and Storage.

  • Monitor and Approve in-process device batches to move to the subsequent phase of operation.

  • Conduct device quality investigations as required including investigations of customer complaints.

  • Assist in the creation and compilation of all device regulatory submissions.

  • Development and maintenance of company device SOP’s.

  • Ensure Design Control procedure is followed for each medical devise

  • Ensuring the design and development of the product is planned and controlled

  • Maintaining up-to-date design plan, ensuring the plan is reviewed, updated, and approved as the product development evolves

  • Coordinate interface management

  • Documenting approved design changes

  • Maintaining the Design History File

  • Coordinating design reviews at the appropriate stages and intervals

  • Scheduling, organizing, and leading the design reviews

  • Final review and sign-off of investigator regulatory packages for device shipment for device clinical trials

  • Interaction with FDA and other regulatory bodies as needed.

  • Manage the Medical Device quality management system ensuring compliance to all applicable medical device regulations.

  • Manage all medical device documentation, SOP’s, Device Master File, Device History Records, Device Specifications, SDS, Inspection records, COA’s, (regulatory listing information to include technical files).

  • Facilitate the Design review process

  • Assist R&D with Design Plan, Control and transfer activities.

  • Assist regulatory affairs with product classification, regulatory pathway guidance and product submissions.

  • Interaction with FDA and other regulatory bodies as needed

  • Oversight for inspection and release activities of incoming device products / components and documentation activities including, but not limited to: Incoming, In Process, and Final Inspection; Change Control, Deviations/CAPA’s, complaints, Monographs, Batch Record Issuance, Storage and release.

 

QUALIFICATIONS AND REQUIREMENTS:

  • BA/BS minimum

  • 5-7 years experience functioning in Quality Assurance in a Medical Device Company

  • Excellent communication skills (written and verbal)

  • Excellent computer skills

  • Ability to travel overnight

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