Sets up, runs and cleans equipment in moderately complex production areas (Dispensing, Charging and Bin Washing in Flows 1-6 or Dispensing or Layering in Flow 7) and makes product following appropriate procedures in a clean and safe work environment meeting with all cGMP, FDA, DEA, OSHA and other applicable regulations (see appendix for specific details).
Performs the Setup, Run and Clean of Dispensed, Manufactured and Packaged product ensuring compliance with and following all appropriate policies, procedures, formula cards, batch records, etc., cGMP, FDA, DEA OSHA and other applicable regulations.
Actively participates and possibly leads Performance Center (PC) meetings.
Maintains and ensures documentation, both written and electronic, is accurate, complete and factual as required by policies, procedures and regulatory guidelines
Holds quality and reliability as high standards of production service and clearly communicates these standards to others.
Provides input and suggestions for process improvements as well as for procedure writing and revision.
Other duties as assigned.
Demonstrated ability and willingness to work and participate effectively in a team environment.
Ability and willingness to maintain accurate and factual hard-copy and electronic records.
Ability to use computers to perform a variety of data-entry transactions and to retrieve information (procedures; safety, employment, and other information). Must be able to use MS Office products (specifically Word, Outlook, and Excel), and perform data entry/maintenance in SAP or equivalent systems.
Attention to detail, safety, quality and customer requirements.
Must possess basic Math skills which include the ability to set up and solve problems involving more than one math operation (addition, subtraction, multiplication, division) on whole numbers, fractions, decimals, or percentages. Must also be able to calculate conversions using a calculator or other device as well as working knowledge of the Metric System.
Demonstrated ability to use measuring devices such as scales, balances, calipers, etc.
Requires a demonstrated mechanical and technical aptitude in order to problem-solve effectively.
Ability to effectively communicate both verbally and in writing to peers and management.
Ability to read information and apply what was described in the reading material to situations which may contain several details or describe processes involving several steps.
Demonstrated high level of personal motivation and initiative.
Ability to learn and apply all relevant Work Instructions (WIs), Standard Operating Procedures (SOPs), and other regulatory requirements.
Ability and willingness to follow directions, as assigned by management, coaches, peers, or in written instructions.
Ability to adapt and be flexible with daily work assignment changes as well as a continuously-improving work environment.
Experience in a manufacturing environment including set-up, operation, cleaning and basic maintenance of manufacturing equipment.
Familiarity with MS Office products (specifically Word, Outlook, and Excel), and SAP or equivalent systems.
Pharmaceutical or other regulatory (cGMP) experience.
May be required to travel.
Notification to Agencies
Please note that Hikma does not accept unsolicited resumes or calls from third-party recruiters or employment agencies. In the absence of a signed Master Service Agreement and approval from HR to submit resumes for a specific requisition, Hikma will not consider or approve payment to any third-parties for hires made.