QA Shop Floor Specialist - 2nd Shift

Job Description

Job Description

Position Summary

The Shop Floor Specialist will provide oversight of manufacturing operations to ensure products are being produced in accordance with cGMP, industry standards and BSM approved procedures. The goal of this role is to contribute to the quality culture and overall success of Berkshire Sterile Manufacturing.

Duties and Responsibilities

• Participate in the preparation, review, issuance and reconciliation and control of QA documents ((Standard Operating Procedures (SOPs), technical reports, risk assessments)) in document management system
• Support evaluation and dispositioning of labelling, raw materials, intermediates and finished products
• Support evaluation of the Master Batch Records (MBR)
• Assist the QA Disposition Specialists in the review Batch Production Record (BPR) laboratory results and other cGMP documents
• Ensure all data integrity requirements are followed by operations and support staff
• Work with QC, Manufacturing, Engineering, Materials Management, Project Management and other departments to troubleshoot quality issues
• Assist with obtaining documentation necessary for change controls, deviations and other GMP documents and review documentation for accuracy and completeness
• Initiate and/or review minor deviation
• Complete tasks related to CAPA and Change Control action items
• Perform internal audits and regular walkthrough visits to the manufacturing areas and prepare associated reports for management
• Review documented information and report abnormalities in functional area
• Prioritize day to day quality support for manufacturing operations and longer-term projects or investigations
• Identify process improvements and other efficiencies
• Assist in the implementation and ongoing support of new processes in the functional area
• Track, interpret and record quality metrics
• Other duties as assigned

Regulatory Responsibilities

• Conduct all work in compliance with FDA, 21 CFR 210 and 211, other regulatory agency requirements and BSM approved procedures

Supervisory Responsibilities

• Integrate knowledge and experience as a skilled specialist to provide guidance and training to lower-level associates on a regular basis

Experience

• One (1) to three (3) years biopharma or pharma experience
• One (1) to three (3) years quality assurance experience
• Familiarity with aseptic manufacturing (formulation, filling, lyophilization) visual inspection, and AQLs preferred

Education

• Associate’s degree in engineering or science discipline or technical certification

Knowledge, Skills & Abilities

• Comprehensive understanding of cGMP, 21 CFR 210/211 and other regulatory agency requirements which apply to quality operations and compliance
• Comprehensive knowledge of QA concepts and principles
• Specialized knowledge of functional procedures and activities within core area
• Experience with Microsoft Office, and general computer proficiency
• Ability to use electronic system such as MasterControl, LIMS, etc.
• Attention to detail
• Well organized
• Problem/situation analysis
• Judgement
• Oral and written communication skills
• Ability to build collaborative relationships
• Ability to work on a team
• Perform complex work instructions and problem solving following established processes
• Apply knowledge base to perform non-routine, variable work instructions and assignments with minimal additional instruction
• Develop solutions for problems of increasing scope and complexity that are creative, thorough and consistent with organizational objectives

Physical Requirements

• Use of standard office equipment with or without reasonable accommodation
• Ability to remain stationary for prolonged periods of time
• Able to walk between work areas
• Ability to periodically lift up to 10lbs.

Wednesday thru Friday
2:00pm to 2:30am