job summary: Primary responsible for quality oversight of GMP documents related to site startup activities. Some of these activities include reviewing and approving GMP documents, communicating with site SMEs for document adequacy, communicating action progress to Sr Manager level. location: Apex, North Carolina job type: Contract salary: $30.00 - 37.96 per hour work hours: 9 to 5 education: Bachelors responsibilities: Candidate will be responsible for; ensuring GMP documents are accurately reviewed and approved in the applicable GMP system in a timely manner, triaging documents to determine adequacy against requirements, follow-up communication with functional SMEs for additional information on GMP documents, completing approvals per required timeframes and providing responses to the Sr Manager level.Candidate will also be responsible for working with other Company departments.Additional responsibilities include prioritizing documents and understanding the importance of accurate review process within the required timeframe, and performing other duties as assigned by supervisor. qualifications: Required: Doctorate Degree OR Master's + 3 years relevant experience OR Bachelor's + 5 years relevant experience.5 years biopharmaceutical experience in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing.Understanding of biopharmaceutical bulk manufacturing and distribution processes.General knowledge of cGMP and filing regulations, practices, and trends (manufacture, testing, distribution of biopharmaceuticals).Self-motivated; interfaces effectively at various levels; attentive to details; understands accuracy/precision.Prioritizes and meets deadlines.Excellent leadership, problem-solving, analytical, and customer service skills for a matrix-managed GMP environment.Well-organized; excellent oral and written English communication skills.Focuses on process improvements.Manages a large number of complex assignments simultaneously.Functions in a fast-paced environment.Evaluates issues, makes quality decisions, and knows when to escalate.Strong project management skills; works in cross-functional teams; handles multiple projects simultaneously.Works effectively in a team-oriented environment with diverse groups.Computer literate; understands/follows/implements instructions independently.Collaborates with outside resources.Possesses outstanding attention to detail and organization skills.Possesses effective decision-making skills. #LI-PV1 skills: SOP, 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: 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.