Jost Chemical Co.
  • 02-Aug-2018 to 31-Dec-2018 (CST)
  • Quality Assurance
  • Koscian, POL
  • negotiable
  • Salary
  • Full Time

QA Program Manager (Poland branch)

Background

  • Works under general administrative direction of the Lab Director in a c- GMP regulated manufacturing environment operating under Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Part II Basic Requirements for Active Substances used as Starting Materials, ICH Q7 standards, and infant formula standards (as an ingredient supplier). Employees in positions allocated to this series are responsible for managing the day-to-day Quality and Compliance Operations.  This position also assists staff with projects and other activities at an operational level.
  • Employees in positions allocated to this level are responsible for managing complex, multiple, concurrent projects and related activities (such as QA that has simultaneous system, process, validation and compliance aspects) within the manufacturing Lab and Research and Development Department.

Tasks

  • Develop, implement and hold group accountable for internal QA programs, systems and

customer requirements; assist staff with projects and activities at an operational level.

  • Develop and implement an environmental monitoring program.
  • Assist in developing Quality policies and procedures for the Poland facility and facilitate having them translated from English to Polish.
  • Supervise assigned staff (such as planning, scheduling, assigning work, monitoring the training opportunities to and for new and existing employees.
  • Ensure adherence to and compliance with established company policies, practices, SOPs and federal regulations.
  • Keep up to date on regulatory changes within the European Union and assure compliance with applicable EU directives and regulations.
  • Ensure quality of raw materials purchased and supplier auditing is conducted.
  • Ensure quality of finished goods manufactured and distributed.
  • Liaison with vendors, customers, staff and management and act as key contact for analytical satisfaction; direct and meet expectations; investigate and resolve customer complaints
  • Define and prioritize tasks/elements (scope, time, costs, quality, communication, resources, contracts, risk and integration) needed to complete assigned projects; keep management informed of progress, issues and resource requirements for assigned tasks/ projects
  • Establish company policies, practices and procedures for GMP compliance
  • Manage third-party audits to defend policies, practices, and procedures related to GMP compliance and act as a subject matter expert for FDA and others during site visits; resolve issues; write reports based on input from internal and external personnel
  • Assure adequate documentation and reporting of procedures and test results; develop methods and track metrics to present data to accommodate a variety of users; write up results and conclusions for publication; present at professional conferences and/or assist in matters of public relations
  • Maintain assigned facilities in neat and orderly manner; review and monitor inventory of supplies and equipment; procure equipment and supplies (including specialized items for which technical knowledge and judgment are essential); maintain and enhance site safety mechanisms/ approaches
  • Make policy and procedure improvements
  • Assist upper-level management in determining objectives, program development and coordinating activities to meet those objectives; assist in budget preparation and special requests; monitor assigned expenditures.
  • Investigate quality issues, identify root causes, corrective and preventative actions
  • Evaluate change for control and customer notification

 

Specifications

  • S. Chemistry or related technical field. (An advanced non-thesis degree may be substituted for one (1) year of required experience listed below; a thesis degree for two (2) years.)
  • Seven (7) years of professional level chemist experience, two (2) years of which as may be gained at the next lower level of this series.
  • Experience in Quality Assurance in a GMP compliant chemical manufacturing setting
  • May require willingness to work evenings and weekend hours
  • Knowledge of:
    • Theories, principles and methods of environmental monitoring program (expert level)
    • Theories, principles and methods of quality assurance program (expert level)
    • Federal, state and local regulations that impact industry (expert level)
    • Mathematics and statistics (broad level)
    • Office methods and procedures (broad level)
    • MS Office software package
    • GFSI (Global Food Safety Initiative) requirements and certification requirements
    • EU GMP requirements and policies
  • Skills in:
    • Working effectively and efficiently on multiple projects at once
    • Working effectively in a team environment
    • Responding to rapidly changing demands
  • Ability to:
    • Plan, direct, supervise and evaluate the work of others
    • Provide training opportunities (directly and indirectly) to staff
    • Manage complex, multiple, concurrent projects and coordinate them with other organizational units
    • Identify, gather, process and record data accurately
    • Assess risk and develop appropriate mitigation approaches
    • Review and formulate policies and procedures
    • Communicate effectively, both orally and in writing, with a wide variety of people
    • Condense scientific/ technical information in to concise presentations/ reports targeted to non- technical management
    • Exercise independent judgment
  • Must have a valid passport
  • Must have or be able to obtain long-term work authorization in the European Union
  • Must have or be able to obtain temporary work authorization in the U.S.
  • Native or bilingual proficiency in Polish required. Minimum full professional proficiency in English required.

FLSA

  • Exempt
Jost Chemical Co.
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