Manufacturing Associate

Position Title: Manufacturing Associate Level 1

Work Location: Walkersville MD 21793

Assignment Duration: 6 Months

Work Schedule: Standard shift begins at 7:30 AM for a daily meeting and ends at 4 PM, Monday through Friday.

Work Arrangement: Onsite

Position Summary:

Responsible for participating in upstream and/or downstream aseptic manufacturing of LAL products in a ISO 5 environment according to company and departmental SOPs. Performs set-up and operate production equipment in the LAL Filling and Finishing areas. Performs product inspections and final kit packaging of finished goods.

Key Responsibilities:

• Operating in a safe work culture (safety chats, safety and EPS observations, 6S)

• Completion of LAL Cleanroom General Training

• Aseptic processing/gowning

• Cleanroom Equipment Set-Up and Usage

• Environmental Monitoring

• Qualification of SAP Transactions (COR3, COR6, MIGO, LS26)

• Completion of LAL Finishing General Training

• Finishing Equipment Set-Up and Usage

• Qualification of SAP Transactions (COR2, COR6, MIGO, MB1A, LB01, LS26)

• GMP Documentation practices

• Product Sample Submission

• Inspection Proficiency Testing

• Inspection Process

• Component Kitting Process

• Continuous Improvement Projects

• Perform job functions with minimal operator related PRs

• Perform aseptic processing with minimal operator related personnel excursions (EM)

• Understand basic level of LAL process flow

• Achieve yearly personnel utilization target

• Maintain training compliance to meet yearly target

• Must be able to demonstrate GMP documentation practices (minimal document errors)

• Must be able to follow standard operating procedures and complete production records

• Understand compliance in the execution of GMPs in a manufacturing environment

• Comply with all safety policies and general regulations

• Perform other duties as assigned.

Qualification & Experience:

• Degree (preferred): Associates in Science

• Language(s) Required: English – Business Fluent

• Work Experience Area: GMP Environment – Entry Level – 0-4 years

• Know-How: Completes standard tasks by applying basic principles and through research and interpretation of factual information; Impacts through accuracy of tasks and information provided (90% accuracy); Contributes to team and builds stable internal department and inter-departmental and external working relationships; General technical & scientific knowledge; Basic process knowledge; Basic math skills; Basic Computer skills; Familiarity with lab techniques and practices (Basic GMP and GDP)

• Problem Solving: Works on problems of limited scope; Uses minimal discretion to complete basic tasks; Minimal troubleshooting – follows instructions; Guided by production schedule, goals and objectives; Follows product specific standards, protocols and/or processes; Rely on team for direction (i.e. work assigned by scheduler); Work is closely monitored

• Impact on KPI’s: Individual contributor; No spending budget, using pre-defined purchasing approval process

• Size & Scope: No direct or indirect reports; Deals with issues of low complexity / high volume; Works under direct supervision

Working Conditions & Physical Demands (If Applicable):

Environmental Demands: The normal working environment is: Production Floor Setting

Physical Demands: Continuous (100%-67%): Bending, Kneeling, Climbing stairs, Climbing ladders, Reaching, Gowning, Standing. Frequent (66%-34%): Walking, Sitting. Occasional (33%-1%): Squatting, Driving, Fine motor skills. Lifting: 50 lbs.

Mental Demands: Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure. Must work well on a team, and be able to trouble shoot and problem solve in a cross-functional team setting. Must be proactive, action oriented, and have the ability to adapt to a change. Must be able to identify and flag risks in a timely manner to keep deliverables on track. Must have strong communication skills both verbally and written. Must be able to support other members of the team through mentoring and training.

Additional Information (If Applicable):

Quality Responsibility: Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

Safety: Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.

Applicant Notices & Disclaimers

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $25.30/hr - $25.80/hr.