Quality Assurance Manager Job at Barrington James, Massachusetts

WXlSaG1UZDBIWmdBNzhENnFhZEhjZ29PUUE9PQ==
  • Barrington James
  • Massachusetts

Job Description

Job Title: Quality Assurance Manager
Location: Massachusetts (Onsite)
Job Type: Full-time

Job Description


We are seeking an experienced Quality Assurance Manager to lead and manage our Quality Assurance (QA) team. The ideal candidate will ensure that all quality processes comply with regulatory standards and align with business objectives. This role involves overseeing the Quality Management System (QMS), maintaining compliance with current Good Manufacturing Practices (cGMP), and fostering continuous quality improvement.

Duties and Responsibilities

  • Supervise and mentor the Quality Assurance (QA) team, including responsibilities for recruitment, training, and performance coaching.
  • Oversee and manage the Quality Management System (QMS), ensuring adherence to regulatory standards for drug quality, strength, identity, and purity throughout production and storage.
  • Develop, implement, and maintain Standard Operating Procedures (SOPs) related to quality assurance activities.
  • Design and implement programs to enhance quality standards and ensure compliance with business and regulatory requirements.
  • Define and enforce inspection standards within the QA department.
  • Conduct and manage internal audits to verify compliance with cGMP requirements.
  • Develop and oversee a company-wide cGMP Training Program.
  • Lead the Change Control Committee, ensuring proper documentation and approval for facility, equipment, product, and process modifications.
  • Review and approve operational procedures related to manufacturing, production, testing, and maintenance, including associated documentation.
  • Ensure proper quality controls are in place and successfully executed during manufacturing operations.
  • Analyze and address any discrepancies found in production records.
  • Serve as the QA department's representative in various organizational meetings.
  • Develop, manage, and monitor the department's annual budget.
  • Oversee the hiring process and manage personnel changes within the QA department.
  • Direct and oversee the daily operations of the QA Department.

Qualifications and Experience

  • Education: B.S. in a Science-related field (Chemistry, Biology, Pharmacy) or equivalent.
  • Experience: Minimum of 5+ years of managerial experience in a QA environment, preferably in the generics pharmaceutical industry.
  • Expertise: Extensive knowledge of cGMP requirements and Quality Assurance functions.
  • Skills: Strong written and verbal communication skills, problem-solving abilities, and attention to confidentiality.

If you are a highly motivated QA professional with leadership experience and a strong background in cGMP compliance, we encourage you to apply.


#QualityAssurance #FDA #generics #Quality #pharmaceutical

Job Tags

Permanent employment, Full time,

Similar Jobs

Old Navy

Old Navy is HIRING! Job at Old Navy

Old Navy is currently hiring!We are holding OPEN INTERVIEWS on Tuesday 3/11/24 & Wednesday 3/12/24 from 12pm until 5pmAgain on Tuesday 3/19/24 & Wednesday 3/20/24 from 12pm until 5pmCome inside the store and ask for the hiring manager!We cant wait to... 

BioLife

Phlebotomist Job at BioLife

 ...Takeda: High school diploma or equivalent Ability to walk and/or stand for the entire work shift Will work evenings, weekends, and holidays Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees Ability to lift to 5 lbs., and... 

Tata Consultancy Services

Architect Job at Tata Consultancy Services

 ...Job Title Veeva CRM Architect Relevant Experience (in Yrs) 6+ Must Have Technical/Functional Skills Veeva CRM, Veeva Align, Salesforce, DFDC deployment Tools (like Copado , Flosum etc.) Experience Required Experience with upstream and downstream applications... 

Yale New Haven Health

Sterile Processing Tech Job at Yale New Haven Health

 ...preparation of trays and equipment, processing of general and specialty...  ..., assembly, wrapping and sterilization, quality control testing,...  ...combination of education and experience and demonstration of current...  ...physical demand inventory of SPD Tech position. Must be able to... 

In House Jobs | JDHuntr

In House Counsel Jobs California | JDHuntr 37537 Assistant General Counsel (remote), Binghamton, NY Job at In House Jobs | JDHuntr

In House Counsel Jobs California | JDHuntr 37537 Assistant General Counsel (remote), Binghamton, NY\ To apply go to JDHuntr.com \ assist Legal department management in providing legal counsel and advice to Executive management, officers and employees with respect to...