Production Filling Operator - Night Shift (8hrs - Mon-Fri) M/F (28100)

WHAT WE'RE LOOKING FOR:

The operator’s responsibilities include filling and inspecting of terminally sterilized and aseptically produced pharmaceutical drugs in accordance with current Good Manufacturing Practices. Operator must understand and adhere to standard operating procedures (SOP’s) in a pharmaceutical manufacturing environment and be able to apply Good Manufacturing Practices. This position also requires successful completion of the training/certification program. This is a 3rd shift position with hours from 10:00pm - 6:30am, Monday-Friday. 

YOUR ROLE:

• Operate filling equipment and handle product within all applicable SOPS, cGMPs, etc.

• Operate equipment within the validated parameters.

• Inspect product to maintain quality standards; perform quality control duties, i.e. sampling of product and environment

• Follow and maintain documentation records, accountability of solution and units throughout the production process.

• Check and verify components.

• Clean/sanitize production areas and equipment.

YOUR DEPARTMENT:

• Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.  Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.  Report all safety and/or environmental incidents to management immediately

• Special projects:  training required for returned goods, reclaim and off-line projects.

• Other duties as assigned with or without accommodation.

MINIMUM REQUIREMENTS

Education Required/Preferred:

• High school diploma, GED, or equivalent

Experience:

• 1-3 years pharmaceutical manufacturing experience within a sterile environment (i.e. ISO 5E or similar)

Preferred Skills/Qualifications/Competencies:

• Ability to lift 50 pounds

• Good math and reading skills

• Mental and visual acuity for production of and identification of quality product

• Good verbal and written communication skills
• Ability to work both on a team and individually

YOUR RESPONSIBILITIES:

• Responsible for reducing product losses and improving yields.

• Responsible for quality of product.

• Responsible for monitoring the process and documenting measurements per SOP.

• Responsible for compliance with FDA, OSHA, cGMP’s

• Responsible for participation in all Safety aspects of the plant.

• Responsible for demonstrating initiative, self-direction and ability to make decisions

• Responsible for demonstrating and support of company policies
   
  Analytical Requirement:

• Able to work flexible hours.

• Requires high degree on manual dexterity, which could be performed under restrictive conditions.

• Mental and visual accuracy is a demand to produce quality product.

• Responsible for good verbal and interpersonal skills in communication.

• Make sound decisions and have good math and reading skills.
   
  Supervisory Responsibility:

• No direct supervisory responsibility; at time must perform with minimum supervision and able to use good judgment and make appropriate decisions
   
  Staff Responsibility:
  N/A
   
  Monetary Responsibility:

• Perform job responsibilities in a manner that focuses on quality as well as positive financial results.
   
  Contacts:

• Daily works with other operators, set-up’s, mechanics and process coordinators.

• Occasional interaction with cross-functional team member on project teams.

• Occasional contact with outside vendors.
   
  Essential Elements:

• Work in areas where special gowning is required.

• Able to visually inspect containers.

• Requires continuous lifting of 50-55 lbs. and operate electric jacks.

• Work in areas where standing or sitting is required for extended periods.