Quality Metrics

Job Title: Quality Metrics

Location- Norwood MA

Key Responsibilities

• Extracting Quality System Metrics from Veeva (or similar eQMS)

• Create, publish, and maintain metrics and reports associated with QMS

• Carries out quality system due diligence and integration activities as required by the business

• High-Level Understanding of Deviations, CAPA, and Change Control workflow

• Data Reporting to support Quality Management Review and APQR (Annual Product Quality review)

• Evaluate metrics and data reporting for key take aways (e.g. On-Time Deviation closure rates)

• Compile data and generate Annual Product Reviews/Product Quality Reviews. Adhere to timelines outlined in pertinent standard operating procedures (SOPs) and communicate the due date to respective departments and upper management.

Skills & Qualifications

• Requires BS/MS degree in Chemistry, Biology, or related field, with relevant experience or equivalent combination of education and experience, preferably in pharmaceutical or biotech Industries, including some supervisory and/or leadership experience.

• Minimum 5-7 years QA, RA, Manufacturing experience in the pharmaceutical industry at USFDA-regulated facilities

• Proficiency in report writing, analysis, and QMS procedures.

• Previous experience with Data Reporting to support Quality Management Review and APQR

• Experience with pulling Quality System Metrics from Veeva (or similar QMS)

• Strong CAPA acumen and change control workflow experience

• Strong ability to evaluate metrics and data reporting for key takeaways (e.g. On-Time Deviation closure rates)

• Ability to comprehend, analyze and interpret process and systems information, technical procedures, reports, and regulations to make decisions in GMP environment

• Highly proficient digital literacy in Microsoft (MS) Word, Excel, PowerPoint, and

SharePoint required. Experience with Quality Management Systems is heavily preferred

• Possess excellent interpersonal, written, and oral communication skills with the ability to use active listening skills to understand concerns or reasoning in order to be responsive, gain trust and build strategic relationships

Job Type: Contract

Salary: From $30.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Norwood, MA 02062: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

Salary : $30 - $-1