Bulking/Formulation Operator

Position : Bulking/Formulation Operator (Required with 2 yrs

Manufacturing Exp & Regulated environment required)

Location : Sparks, MD

Duration : 12 Months

Total Hours/week : 40.00

1st 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 in-process 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 on-boarding 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 non-technical 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 semi-routine 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.