QA Specialist III - Batch Release (1st shift)

Work Schedule

Environmental Conditions

Job Description

POSITION SUMMARY

In this position youll drive quality execution across the sterile operations including manufacturing filling packaging and inspection and associated non batch specific activities in for both commercial and product development services products. Additionally this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours are 8:00a - 4:30p Monday through Friday.

Key Responsibilities:

• Perform daily quality assessments of facility personnel and documentation both classified and non-classified areas to uncover errors or deficiencies assure quality and compliance per site procedures and cGMPs.

• Daily interaction with employees to assist with troubleshooting documentation corrections/notes and guidance with aseptic technique

• Champion quality culture by aiding personnel in understanding application of policies and controls

• Participate in RAPID event response and provides quality guidance for deviation events

• Advance deviation events to the appropriate area and quality management

• Perform quality review and approval of procedures training documents deviation and change control and forms of moderate to high complexity

• Participate as the quality assurance representative in Root Cause Analysis to support deviation investigations of moderate to high complexity

• Perform quality batch record review

• Aid in identification of continuous improvement opportunities; Participate in practical process improvement initiatives

Qualifications:

• Bachelors degree preferably in technology engineering or microbiology related field required.

• A minimum of 4 years of experience in Quality Assurance or Quality control or Operations/Manufacturing

• Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred experience in other regulated environments may be considered (i.e. ISO 9001)

• Effective time management and prioritization skills.

• Ability to troubleshoot process and equipment issues

• Ability to lead support & empower a team/peers

• Technical Writing experience

• Professional certifications (ex: CQA) and training (Six Sigma) is a plus

• Ability to function independently and as part of a team.

• Understanding of the Quality systems and investigation documentation
  

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand walk stoop kneel crouch periodically for prolonged periods of time Manipulation (lift carry move) of light to medium weights of 10-35 pound pounds. Arm hand and finger dexterity including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard computer monitor operate equipment and read materials for prolonged periods of time. Ability to sit reach with hands and arms talk and hear for prolonged periods of time. Safety glasses safety shoes lab coat nitrile or similar gloves safety apron organic respirator occasionally.

BENEFITS

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.

Apply today!