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Biologics Validation Specialist

Synectics Inc. Devens ,MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Description:
Quality Assurace (QA) review and approval of technical documents pertaining to GMP analytical methods for biologics drug substances and drug products. The scope of documents will range from early clinical development through registration and commercial life cycle.
Specific technical document types include the following:
Analytical method procedures
Method validation protocols and reports
Method transfer protocols and reports
Reference standard and critical reagent qualification protocols and reports
Certificates of analysis
Change controls and general procedural documents.
Partner with analytical functional areas to resolve associated deviations and other exceptional conditions
Assist with CAPA identification and resolution.
Perform the QA review/approval of technical documentation
Analytical method validation protocols and reports for in process, release, and stability testing
Analytical method procedures and associated change controls
Method technical transfer protocols and reports
Reference material and critical reagents qualification protocols and reports
Standard Operation Procedures and other controlled documents
Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations and exceptional conditions related to validation or technical transfer of analytical methods or qualification of reference material and critical reagents
Communicate, share and escalate issues within team for consensus resolution
Assist in the development of procedural and other guidance documents for Quality and QC functions

Qualifications:
Working knoweldge of QC, QA, analytical method development or method validation functions
Less than 8 years of biologics and/or pharma industry experience and minimum 2 years of QA experience.
Understanding and knowledge of FDA guidelines and GxP regulations.
Excellent communication, attention to detail, relationship management, negotiation, problem-solving and personal time management skills
Ability to manage multiple priorities with aggressive timelines   
Minimum of 5 years professional experience in Biologics Quality Assurance, Quality Control, analytical chemistry, method development is desirable
Previous experience in QC laboratory facing QA activities is highly desirable (i.e. OOS, OOT, laboratory related deviations)
Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity, PDLIMS, Trackwise) is desirable.
Experience and/or knowledge of QC biologics testing
Working knowledge of GMP environment is desirable

 

 

Company Description
Synectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States. We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling. We also seek to justify our clients’ expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day. Our success has depended on our consistent ability to achieve both of these goals.

Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum. In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds. This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.

Synectics Inc.

Synectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States. We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling. We also seek to justify our clients’ expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day. Our success has depended on our consistent ability to achieve both of these goals. Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum. In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds. This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.

Address

38 Jackson Road Devens; MA 01434
Devens, MA
USA

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