Quality Assurance Specialist

job summary:
In this position, you'll 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.

location: Greenville, North Carolina
job type: Contract
salary: $18 - 26 per hour
work hours: 9 to 5
education: Bachelors

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

- Champions quality culture by aiding personnel in understanding application of policies and controls

- Participates in RAPID event response and provides quality guidance for deviation events

- Advances deviation events to the appropriate area and quality management

- Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity

- Performs quality review and approval of deviation and change control of moderate to high complexity

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

- Performs quality batch record review

- Aids in identification of continuous improvement opportunities; Participates in practical process improvement initiatives

qualifications:

Required:

- Bachelor's degree, preferably in technology, engineering or microbiology related field required.

- Equivalent combinations of education, training, and relevant work experience may be considered

- A minimum of 4 years of experience with previous 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)

- Ability to capture data, analyze & troubleshooting process issues, equipment problems along with production leadership

- Ability to troubleshoot process and equipment issues

- Hard-working, demonstrated ownership & responsibility.

- Ability to lead, support & empower a team/peers

- Technical Writing experience

- Professional certifications (ex: CQA) and training (Six Sigma) are a plus

- Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning.

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.

skills: Microbiology, Aseptic Technique, Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Control (QC), Aseptic Processing


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.