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Quality Assurance Specialist II (Temp-to-Perm)

Location: Chelsea, MA, Massachusetts

Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:


Date Posted: 4/24/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Quality Assurance Specialist

Industry: Engineering

Location: Boston, MA 02108

Employment Type: Full Time, Contract to Permanent

Pay Range: 36-38/hr.

Duration: Contract to Permanent

Job#: bh9881


Quality Assurance Specialist

-They are looking for someone with roughly 3-5 years of experience

-Must have GMP experience

-Ideally someone who has experience working in a Biopharma manufacturing environment

-As a QA Spec. one really needs to be an investigator and show evidence from their career that they have performed really in-depth analysis because this is a vital aspect in being able to perform well at this job.

The Quality Assurance Specialist - Operations is responsible for supporting operations in a GMP Manufacturing Facility. This individual provides oversight of production activities with limited supervision.


*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of Discrepancies
  • Oversight (with limited supervision), review, and approval of Materials Management and Supply Chain activities
  • Support of Environmental Monitoring Program for Chelsea Facility, including Controlled Environments and Clean Utilities
  • Revision and/or review and approval of SOPs, Protocols, Reports, and Master Batch Records for continuous improvement
  • Initiation of Discrepancies, including Deviations and Investigations.
  • Support of implementation of CAPA as determined through Discrepancies
  • Review and approval of Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods
  • Disposition of controlled materials (Work in Progress, Finished Product, and Raw Materials)
  • Provide basic support during compliance inspections conducted by external sources (i.e. health authorities)
  • Support GMP manufacturing shifts as needed, including participation in shift change/floor meetings with the operators

Education and/or Experience:

  • Bachelor’s degree in a scientific discipline is required, preferably in physical Science or Chemistry.
  • Minimum of 3-5 years of progressive experience in a GMP environment required.
  • Minimum of 1 year of Quality Assurance experience in support of GMP production required.

Supervisory Responsibilities: None


  • Working knowledge of GMPs and their application to pharmaceutical manufacturing required.
  • Previous exposure to investigations and product complaints preferred.
  • Must be able to interpret applicable standards and objectively make decisions with support of management.

Computer Skills:

  • Must be proficient in MS Office Suite.
  • Experience in the use of Material Requirements Planning (MRP) systems preferred.

Certificates, Licenses, Registrations:  none required

Other Skills and Abilities:

  • Excellent verbal and written communication skills.
  • Ability to manage both day-to-day operations as well as project work in a fast-paced environment.
  • Ability to work both independently and in a collaborative team setting.
  • Ability to accept multiple tasks and adjust priorities, as assigned.
  • Demonstrated ability to stay abreast of trends and new information in the profession.
  • Excellent organizational skills and attention to detail are required.


When responding to this job posting you MUST include the Job# and Job Title in your subject line.


Contact Info:                                                                                                                                             


ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776