Quality Assurance

Integrated Resources Inc.; Andover (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading staffing firm seeks a qualified QA Validation specialist in Massachusetts. The candidate will focus on reviewing validation documentation in a regulated environment, ensuring compliance with global GMPs. Candidates should possess a BS degree in a related field and have a minimum of three years of relevant experience in QA or validation within the pharma/biopharma industry.

Qualifications

• Minimum 3 years experience in a QA or validation role in pharma/biopharma.
• Strong working knowledge of global GMPs and computer validation.
• Detail-oriented with strong interpersonal and communication skills.

Responsibilities

• Review and approve validation documentation including specifications and protocols.
• Support data integrity initiatives at the site.

Skills

Interpersonal skills

Oral communication

Written communication

Attention to detail

Education

BS in biology, engineering or related sciences

Tools

Labware

Trackwise

Documentum

Job description

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

· The scope of work for this role is to provide QA Validation support to validation activities associated with Quality Control (QC) Laboratory instruments. The main responsibility is review and approval of validation documentation including specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the site’s data integrity initiative

· Successful candidate requires a strong working knowledge of global GMPs with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.

· Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation, Instrument Validation and QC personnel.

· Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation.

· Candidate must have at a minimum a BS in biology, engineering or related sciences with at least 3 years of pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation role.

· Past experience working with QC instrumentation, Labware, Trackwise, and/or Documentum in the pharma/biopharmaceutical field is preferred but not required.

Qualifications

· Minimum BS in biology, engineering or related sciences with at least 3 years of pharma/biopharma experience in a QA or validation role

· Strong working knowledge of global GMPs with emphasis on validation, including computer validation

· Strong interpersonal, oral and written skills

Additional Information

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Sr. Clinical Recruiter

Integrated Resources, Inc.

(Direct) 732-844-8720| (F) 732-549-5549

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