CTG Change Control Analyst in Fremont, California

Title: Change Control Analyst

Location: US-CA-Fremont

Job Number: 18203413

Come join us and grow your career with CTG! Apply now for immediate consideration for this exciting opportunity.

Job Title: Change Control Analyst

Location: Fremont, CA

Duration: 8 months, W2 Contract

Overview

  • Must be a self -driven Change Control Analyst, with one to four years’ current experience

  • Minimum of a BS degree is mandatory

  • Requires one to four years’ current experience in the administration of the change control process

  • Will liaise with Project Managers, change requestors, management and operational teams concerning change requests, checking accuracy of content, status, and compliance with cGMP documentation practices

Job Responsibilities

  • Ability to maintain confidential information, to meet deadlines, to manage priorities, to have accuracy and attention to detail is critical

  • Assure that change records are readily retrievable and in inspection-ready condition

  • Checks and verifies that change orders are accurate, properly cross reference all affected documents, and meet requirements for compliance with external customers, internal documentation and cGMP documentation practice

  • Demonstrated proficiency level with Microsoft Office products required

  • Demonstrates understanding of Quality Systems fundamentals, Electronic Quality Systems Management Systems (eQMS) (preferably MasterControl); must show ability to operate on multiple systems and software

  • Demonstrates knowledge of the process, effects, and the relationship between the change process and products, and understanding of current Medical Device industry and applicable regulations including 21CFR820, ISO 13485, ISO 14971

  • Coordinates sending out task emails, scheduling meetings as necessary between impacted functional areas and manages of Change orders for review and approval

  • Supports the correct and timely implementation of Change Requests from R &D departments

  • Organize the approval case load across several competing projects to ensure approvals occur in a timely manner

  • Provide recommendations to Change Requestors

  • Work collaboratively with change requestors to ensure quality compliance

  • Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues

  • Provides support to internal and regulatory audits/inspections as required

Required Skills (MUST have to be considered)

  • Ability to convince and influence others.

  • MS Excel (or equivalent SW experience) to organize information and data

  • Ability to work in a fast paced environment.

  • Good written and verbal communication skills

Required Education

  • BS Degree plus up to 4 years of current experience in the medical device, biopharmaceutical / pharmaceutical or a related industry

  • MS Degree plus up to 2 years of experience in the medical device, biopharmaceutical / pharmaceutical or a related industry

Additional Information

  • No third party resumes accepted

  • Drug testing and/or other employment-related inquires may be conducted

  • W2 only, no C2C or 1099 arrangements available

  • Candidates must currently reside in USA or Canada

  • CTG is an Equal Employment Opportunity employer

  • CTG is an E-Verify Company

To be considered for this opportunity, please apply directly through our website by clicking the link below or email your MSWord version resume to Maurine.Mercer@ctg.com. Please reference CTG job number 18203413 when applying!

Qualifications:

CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.

CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).

CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.

CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.

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