Project Specialist I

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. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

location: Morrisville, North Carolina
job type: Contract
salary: $45 - 50 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:
Ensuring quality and compliance of Investigational Medicinal Products used worldwide.

The responsibilities include some of the following:

- Serve as a Batch Release Officer for the review and recommended release of

documentation for a range of dosage form batches and finished clinical trial packs of

Investigational Medicinal Products in accordance with GMP requirements.

- Assessment of Quality QMS Records (e.g. Deviations and third party or internal

complaints), make recommendations for corrective and preventative actions and to follow

up on the implementation of those recommendations.

- Review and Approve GMP documentation, which may include Standard Operating

Procedures, Change Controls and other controlled documents from business partner areas such as Clinical Supply Chain packaging operations and logistics

- Provide advice and support to business partner areas relating to quality matters and

process improvement.

- Develop and incorporate effective processes and procedures in Quality R&D Supply

QA/QP US and may contribute to business processes and procedures outside of quality

- May participate in Audit/assessments as well as multiple projects of high priority

including regulatory inspections and high-risk non-compliance issues.

- Participate in or lead improvement initiatives

qualifications:

Basic Qualifications:

- Bachelor's degree or equivalent work experience such as 5+ years in similar position

- Experience of QA review of GMP Manufacturing and/or Packaging Documentation

and/or laboratory records of pharmaceutical dosage forms which may include sterile

products and/or review and approval of GMP documentation within a Quality

Assurance/Quality Control role.

- Experience of knowledge of GMP principles and being a decision maker using this

knowledge

- Experience leading or participating in QMS activities (e.g. Quality Deviations, third

party/Internal Complaints, Change Controls and inspections/audits and root causing)

- Proficient working knowledge of Microsoft Windows suite of applications (Word, Excel, Power Point)

Preferred Qualifications:

- Experience working in high pressure environments where there are likely to be

conflicting priorities

- Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging.

- Strong attention to detail

- Good communication skills with the ability to build relationships and trust; and make

decisions based on GMP principles. problem solving and collaboration

skills: Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Management Systems (QMS)


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.