BulkingFormulation Operator 3

Position : Bulking/Formulation Operator (Required with 2 yrs

Manufacturing Exp & Regulated environment required)

Location : Sparks MD

Duration : 12 Months

Total Hours/week : 40.00

1^st Shift

Client : Medical Devices Company

Job Category : Light Industrial

Level of Experience : Entry Level

Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Workdays/hours: 5am 3:30pm Monday thru Thursday.

Overtime required on Fri and Sat as needed.

******Will require a respirator fit test. Must be clean shaven for this position and will require wearing a respirator! No exceptions!!********

Job Description:

• Responsible for preparation of materials to support downstream manufacturing operations.
• May operate specialty preparation equipment.
• Weighs measures and checks raw materials to ensure batches manufactured contain proper ingredients and accurate proportions following approved procedure.
• Assists with in process testing to ensure batches meet specifications.
• Responsible for validating processes and equipment directly related to filtration cleaning and sterilization.
• Responsible for the removal and disposal of waste chemicals solvents and acids. Identifies troubleshoots and resolves complex issues associated with bulking/formulation operations.

Responsibilities and Duties:

• Weighs measures and checks raw materials to ensure batches manufactured contain proper ingredients
• Performs simple analytical tests (pH conductivity and absorbance)
• Performs routine cleaning of processing equipment
• Handles hazardous waste as appropriate
• Assists with inventory counting activities as required
• Inspects inprocess parts to ensure consistent quality and remove defective product packaging and component material
• Responsible for ensuring timely and accurate documentation of all manufacturing activities performed
• Monitors meters gauges temperatures pressures and related controls
• Plans and controls timing of operations
• Generates reports graphs and other data
• Ensures accurate proportions of batches following approved procedure
• Interprets complex drawings diagrams charts and specifications
• Performs complex work to close tolerances high quality and accuracy
• Makes effective decisions relative to position requirements
• Evaluates operating process equipment and implantation to ensure constant compliance with standard manufacturing practices (SMP)
• Uses independent judgment in troubleshooting and problem solving under little/no supervision
• May develop weekly production plans coordinating resources (raw materials) and communicating relative priority to downstream parties
• Provides support to lead and/or supervisor when necessary
• May provide training support for onboarding and/or new procedures
• May provide support on special projects
• Demonstrates the ability to follow established procedures according to Good Manufacturing Practices (GMP)
• Must follow all client housekeeping policies and procedures
• Must follow all client safety policies and procedures
• Must be able to work overtime as required to meet client business requirements
• Perform other duties as required

Qualifications

Minimum Education/Experience:

• High School degree required with 2 years manufacturing experience required. Experience in a regulated environment required.

Basic Skills:

• Exhibit the ability to use independent judgment and demonstrated leadership
• Possess the ability to communicate (oral/written) technical and nontechnical information across the group and organization
• Possess strong time management skills to complete assigned tasks in an accurate and timely manner
• Strong attention to detail
• Possess the ability to operate independently on semiroutine and routine activities

Proficient/Working Skills:

• Must be proficient in English with the ability to read write analyze/evaluate charts follow simple diagrams and perform basic arithmetic
• Demonstrate the ability to use personal computers
• Proficiency in MS Excel is required
• Must be able to use advanced math skills to produce accurate formulas
• Possess the able to read write comprehend and interpret complex charts drawings diagrams graphs and other data
• Must be able to climb steps.