Recent Searches

You haven't searched anything yet.

2 QA Shop Floor Specialist I Jobs in Lee, MA

SORT BY
SET JOB ALERT
Details...
QA Shop Floor Specialist I
Berkshire Sterile Manufacturing
Lee, MA | Full Time
$73k-89k (estimate)
11 Months Ago
QA Compliance Specialist I
Berkshire Sterile Manufacturing
Lee, MA | Full Time
$63k-78k (estimate)
11 Months Ago
QA Shop Floor Specialist I
Berkshire Sterile Manufacturing Lee, MA
$73k-89k (estimate)
Full Time | Pharmaceutical 11 Months Ago
Save

Berkshire Sterile Manufacturing is Hiring a QA Shop Floor Specialist I Near Lee, MA

Position Summary

The Shop Floor Specialist II 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.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$73k-89k (estimate)

POST DATE

05/06/2023

EXPIRATION DATE

05/10/2024

WEBSITE

berkshiresterilemanufacturing.com

HEADQUARTERS

LEE, MA

SIZE

100 - 200

FOUNDED

2014

TYPE

Private

CEO

SHAWN KINNEY

REVENUE

$10M - $50M

INDUSTRY

Pharmaceutical

Related Companies
SERES THERAPEUTICS INC. Ocular Therapeutix, Inc. iZotope Sigilon Therapeutics Inc
About Berkshire Sterile Manufacturing

BSM is a bio-pharmaceutical company that develops and manufactures sterile drug products for clinical applications.

Show more

Similar Jobs

Floor Care Specialist
View Jobs
Flooring Specialist
View Jobs
Flooring Measure Specialist
View Jobs
Qa Compliance Specialist
View Jobs
Qa Document Control Specialist
View Jobs
Qa Documentation Specialist
View Jobs

Popular Articles

Top 10 Things to Avoid Putting on a Job Application Read Article How to Describe Your Education in a Resume Read Article How to Write a Memorable Cover Letter in 5 Ways Read Article 4 Personal Finance Tips to Make During Job Transition Read Article 4 Best Camera Setups for Interview Read Article Keeping a Job Search Journal: 9 Types of Journaling You Can Do Read Article