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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

QA lead technical operations

Job Description

  • Location: Devens, MA
  • Type: Contract
  • Job #74663

Our client, a leading pharmaceutical company, is hiring a QA Lead Technical Operations consultant on a contract basis.

Work Location
Devens, MA/Hybrid

Summary

Hybrid role- Minimum 50% onsite and some activities can be done remote and other activities must be done onsite
• Strong background in Validation, Engineering, QA Computer System Engineer, or QA Engineering.
• Provides Quality Assurance (QA) support to Devens Site and reporting Manger through quality review and approval of Investigations and Corrective Actions.
• Decision making of non-conformance through a deep understanding of Quality Systems Regulatory expectations
• Reviews and approves Quality, Quality Control, Validation and Automation related documents
• Review and approves Standard Operating Procedures (SOPs).
• Review and approval of Validation related documentation such as risk assessments, protocols and test scripts and summary reports.
• Review and approval of change proposals as well as associated deliverables, ensuring the change deliverables meet external regulatory and internal WWQC guidelines and requirements.
• Ability to coach across different departments within the subject matter of Investigations, CAPAs, general risk assessments and Validation.
• Ability to self-manage and prioritize work across multiple competing deliverables, in a remote working environment
• Able to interpret complicated data and make sound decisions, Independently

Preferred some project management experience.

This position will regularly interact with:
Reporting Senior Manager

Sometimes will interact with departments listed below:
Quality Control
Manufacturing Operations
Manufacturing Engineering
Manufacturing Science and Technology (MS&T)
Validation
Site Engineering
Digital Plant

Qualifications:
Knowledge of science generally attained through studies resulting in a B.S; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
• Greater than 12 years of relevant experience in a GMP, GCP, or GXP with at least 10 years focused on product quality. Preferred Active member of ASQ or ISPE.
• Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing is highly desirable.
• Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
• Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, Veeva Vault and electronic or paper based batch records desirable.
• Excellent Technical writing and oral communication skills are required.
• Background in problem solving
• Knowledge of Data integrity principles
• Proven attention to details
• Comfortable working in an FDA regulated environment.

Pay Range:  $65-$67
 

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