Job Description

job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you\'re looking to be a part of an impactful team, you won\'t be disappointed!

This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.

location: Marion, North Carolina
job type: Contract
salary: $35.00 - 37.85 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Lead ongoing daily departmental activities for areas of direct responsibility including supervision of assigned personnel, and when required assist other Quality areas in the successful performance of these activities.
• Manage activities of self and direct reports in achieving defined quality goals in an efficient, accurate and timely manner.
• Be directly involved in and where appropriate lead multiple process/product improvement projects which may include any of the following - PMT, QWT, Kaizan, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
• Lead in-plant audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Company quality requirements. Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
• Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility.
• Provide guidance and coaching for the areas of responsibility as defined in items # 1 through #5 for less experienced individuals within the plant.
• Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
• Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis.
• Assists and writes validations for equipment, product changes and computer systems.
• Assists with vendor audits/assessments and provides ongoing feedback related to quality issues.
• Sustain a clean and safe work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

qualifications:

• Bachelor\'s degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with Ph.D. is ideal. Lead Auditor training, ISO Lead Assessor training, with 2-3 years\' experience in auditing techniques, interpreting regulations and quality systems. Minimum of 5-8 years of experience in Quality, or related field in the medical products industry.
• Understand scientific strategies and be able to invent new methods or new avenues of investigation.
• Good interpersonal/communication/influencing/negation skills.
• Good project management skills
• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to communicate with other team members.

skills: Quality control, SOP, FDA, Quality Assurance, GMP (Good Manufacturing Practice)

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 HRsupport@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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Randstad