Job Description

• 3 POSITIONS AVAILABLE*
• Candidate will be working on site
• 2+ years of Pharma or Biotech manufacturing/laboratory or manufacturing support
• Analytical testing experience
• Shift: 7a-4p, must be flexible due to production demand, some weekends required

Top 3 Must Have Skill Sets:

Manufacturing GMP experience in biotech field Analytical testing experience, preferably in QC Flexible schedule based off production demand

This is a manufacturing support role responsible for manual visual inspection and testing in manufacturing operations teams. This Senior Associate position will be focused on:  Characterization, sample, data, and equipment management  Process improvement projects/assignments within operations  Quality systems (Deviations/CAPA/CAPA EV/LIMS/MES/SAP/MAXIMO) support  Support new product introduction activities  Support production  Maintain open communication between operations teams This Senior Associate position will be focused on manual visual inspection and testing in manufacturing operations. Job Scope and Responsibilities:  Under minimal supervision, performs manufacturing and laboratory unit operations according to Standard Operating Procedures  May schedule operations for multiple functional areas  Understand process parameters and can identify process anomalies  Perform data analysis of critical process parameters  Operate complex critical processing equipment  Assist, plan and implement continuous improvement solutions related to routine functions  Assist in ensuring operations are completed per manufacturing schedule which may include delegation of tasks  Primary resource related to processing operations on the mfg floor/laboratory  Identify and propose solutions to complex problems  Responsible for resolving problems during operations  Perform initial review of manufacturing/laboratory procedures/batch records  Review, revise, and audit documents  Ability to perform computer operations (MES, EBR, MAXIMO, LIMS and SAP Knowledge)  May own deviations/CAPA or provide suggestions/ideas for corrective actions and preventative actions for deviations/safety incidents  Applies research, information gathering, analytical and interpretation skills to problems of diverse scope  Utilizes basic project management skills to set project timelines and priorities based project objectives and ongoing assignments  Recognizes and escalates problems  Able to establish working relationships with others outside area of expertise  Ability and willingness to support flexible shift structure in support of operations (may include 24/7 or weekend)  Ability to understand, apply, and evaluate basic chemistry, biology, and physical principals as appropriate for the position  Organizational skills and an ability to perform assignments with a high degree of attention to detail  Written and oral communication skills. Technical writing capability  GMP knowledge with ability to interpret and apply applicable regulations  Ability to understand analytical methods for manufacturing/laboratory area And Prior experience with lab equipment, computers, and intermediate mathematical skills Preferred Qualifications:  Experience with manual visual inspection and/or laboratory in a GMP regulated environment.  Experience with PAS X Werum software for electronic batch records with some understanding of editing and validation  Degree in Engineering, Chemistry, Biochemistry, Biology or Computer Science with experience in biotechnology  Demonstrated technical writing skills  Strong knowledge of manual visual inspection and laboratory background or strong understanding of related disciplinary areas in bioprocessing (Drug Product operations)  Demonstrated ability to work in a team

Qualifications

Basic Qualifications: Bachelor’s degree and 2 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) Or Associate’s degree and 5 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality) Or High School Diploma/GED and 8 years of experience in a biotech/pharma manufacturing/laboratory or manufacturing support (i.e. laboratories, engineering, facilities, quality)

Additional Information

TOP 3 MUST HAVE SKILL SETS:

Manufacturing GMP experience in biotech field Analytical testing experience, preferably in QC Flexible schedule based off production demand