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Sr. Quality Control Environmental Analyst/Team Lead

Employer
Nitto Avecia Pharma Services
Location
Milford, MA, United States
Start date
Jan 2, 2019

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Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown
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Job Details

Purpose of Position:

The QC Environmental Team Leader functions as the group SME and ensures that all procedures and programs supporting environmental monitoring and water system testing adhere to all regulations, guidelines, and industry standards for a non-sterile API manufacturer. The Team Leader represents Avecia and the QC departments microbial monitoring program during quality, regulatory and client audits.

Key Job Responsibilities:
  • Oversee and perform QC sampling and testing for the water and environmental monitoring, including oversight of work performed by contract labs.
  • Coordinate with contract laboratories for courier services, sampling, and testing, as required.
  • Monitor and trend environmental data in accordance with SOPs and author and assure timely completion of alert and action documents as required.
  • Coordinate with Manufacturing, QA, and Facilities departments in all microbial system updates, requirements, and ongoing trending.
  • Supervise staff in conjunction with company policies and procedures, including performance management, goal setting, and coaching
  • Assist in audits of contract labs.
  • Support the timely completion of MFG product and facility risk assessments related to microbial control strategy
  • Recommend and implement best practices for micro and EM program and facility control strategy.
  • Support validation efforts for micro and EM program, which may include authoring and/or reviewing contracted protocols, reports, deviations, CAPA.

Job Knowledge Required:
  • BS in microbiology or related discipline
  • 5+ years of experience in a pharmaceutical microbiology laboratory environment including environmental monitoring and water system testing.
  • Working knowledge of cGMP
  • Interpersonal skills to effectively lead and supervise a group
  • Prefer at least 2 years of direct supervisory experience.

Equal Opportunity Employer

Company

With over 25 years of experience in oligonucleotide development and production, and over 1000 sequences manufactured, Avecia has played an integral role in the advancing oligo therapeutic market. Our mission is to continue to build value for our customers, as they progress through drug development into commercialization. And as a member of the Nitto Denko Corporation (www.nitto.com), Avecia is committed to the future of the oligonucleotide market. We are driven by innovative ideas and flexible solutions, designed to provide our customers with the best in service, quality, and technology.

Additional locations:

33 Locke Drive
Marlborough, MA 01752
 
8560 Reading Road
Cincinnati, OH 45215
Tel: (513) 679-3000

Company info
Website
Mini-site
Nitto Avecia Pharma Services
Phone
+1-949-951-4425
Location
10 Vanderbilt
 Irvine
CA
92618-2010
US
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