Manufacturing Compliance Associate (462)
- Employer
- Nitto Avecia Pharma Services
- Location
- Milford, Massachusetts, United States
- Start date
- Sep 14, 2019
View more
- Discipline
- Manufacturing & Production, Manufacturing/Mechanical, Regulatory
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Genetown
Job Details
Purpose of Position:
The Manufacturing Compliance Associate position is responsible for supporting all compliance (Quality and Safety) investigations and corrective actions, as well as the origination and revision of quality documentation in support of the Manufacturing group. This person will work with Manufacturing managers, supervisors, and leads to assure the growth and maintenance of a quality and safety compliance culture.
Key Responsibilities:
Facilitate, document, and review compliance related investigations to ensure root causes are identified, corrective actions implemented, and the effectiveness of these corrective actions fulfill regulatory and business requirements.
Support project team with originating and revising manufacturing related SOPs and batch records.
Supports audits of all quality and safety compliance systems including safety analysis/risk assessment, 5S, training, documentation, and general manufacturing operations to assure continual compliance.
Would support on time performance within the department using visual management tools.
Support training opportunities for manufacturing staff in the areas of quality and safety compliance.
Provide technical writing support for quality investigations and assure standards for investigational reporting are met.
Job Knowledge Required:
A BS in a technical discipline is required, Chemistry, Biology, Engineering preferred.
3-5 years of experience in a cGMP pharmaceutical manufacturing environment with demonstrated experience writing investigations and other quality documents.
Experience leading departmental and cross-functional teams through effective peer-to-peer influence is strongly recommended.
Lean/SS certification is preferred.
Must have strong technical writing and communication skills.
Experience leading root cause analysis is strongly recommended.
Must be experienced with standard Microsoft business applications and proficient with Excel graphing tools. Knowledge of statistical software tools is preferred
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
- Website
- http://www.avecia.com/Avecia/
- Mini-site
- Nitto Avecia Pharma Services
- Phone
- +1-949-951-4425
- Location
-
10 Vanderbilt
Irvine
CA
92618-2010
US
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