Affymetrix

Careers

At Affymetrix, we offer our employees a comprehensive, competitive program of benefits
and a corporate culture based on core values of innovation, excellence and integrity.


Agency Temp

Business Title: QC Engineer 1
Req ID: 11015
Employment Type: Temporary
Full-Time/Part-Time: Full Time
Location: United States - Cleveland, OH
# of Openings: 1
Functional Area: Quality & Regulatory

Description

Affymetrix, now part of Thermo Fisher Scientific

Position Summary:

A QC Engineer designs, implements and maintains quality control protocols and methods for qualifying materials in partially finished or finished products.  Responsible for planning, implementing and managing compliance of testing processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution.  Designs methods and procedures for inspecting, testing and evaluating raw materials, intermediates and finished products.  Performs analysis of reports and testing data to identify trends and recommend updates or changes to quality standards and procedures when necessary.  May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).

 

Primary Duties/Responsibilities:

  • Performs analysis of product and raw materials
  • Plans product investigations and troubleshooting activities and prepares investigation summaries and reports
  • Creates, revises and updates standard operating procedures as needed
  • Contributes to test method development and validation
  • May contribute to special troubleshooting projects and product investigations
  • Compiles data for documentation of test procedures, stability program testing and formulation studies
  • Participates in the calibration and maintenance of lab equipment
  • Maintains validation and preventative maintenance schedules and records
  • Works cross-functionally to efficiently release product, resolve problems and support sales
  • Participates in process and operation improvement opportunities
  • Responds to internal and external  inquiries
  • Complies with company quality management systems, policies and procedures including self-training activities
  • Provides mentorship, if applicable
  • Additional duties/responsibilities according to business needs

 

 

 

Requirements:

Required

Preferred

Education:

Bachelor’s (Chemistry, Biology or related discipline)

Master’s, preferred Chemistry

Yrs of related experience:

1-2 years

1-2 years

Competencies: (skills, knowledge, abilities)

Interpersonal skills, Results oriented, Lab skills, Ability to adapt to changing priorities, MS Office

HPLC, Technical writing, Program Project Management

Licenses/Certificates:

None

None

Travel Requirements:

As necessary

As necessary

Working Conditions:

Office and Lab Environment

Office and Lab Environment

 

Level of Autonomy and Complexity:

  • Minimal use of basic principles, theories, concepts to resolve typical issues
  • Complies with standard practices and procedures to solve routine issues of limited scope
  • Impact restricted to processes related to assigned tasks; error or failure to achieve objectives have no significant impact on organization
  • Receives precise directions on tasks; work is intently supervised

 

 





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