Specialist Quality Assurance Position Available In Wake, North Carolina

Job Description:

Payrate:

$30.00 – $33.00/hr. Not sure what skills you will need for this opportunity Simply readthe full description below to get a complete picture of candidaterequirements.

Summary:

Primary responsible for quality oversight of GMP documents relatedto site startup activities. Some of these activities includereviewing and approving GMP documents, communicating with site SMEsfor document adequacy, communicating action progress to Sr Managerlevel.

Responsibilities:

Candidate will be responsible for; ensuring GMP documents areaccurately reviewed and approved in the applicable GMP system in atimely manner, triaging documents to determine adequacy againstrequirements, follow-up communication with functional SMEs foradditional information on GMP documents, completing approvals perrequired timeframes and providing responses to the Sr Managerlevel. Candidate will also be responsible for working with other Companydepartments. Additional responsibilities include prioritizing documents andunderstanding the importance of accurate review process within therequired timeframe, and performing other duties as assigned bysupervisor. Doctorate degree OR Master’s degree & 3 years ofexperience directly related to the job OR Bachelor’s degree & 5years of experience directly related to the job

Skills:

Strong project management skills, experience working incross-functional teams, and the ability to handle multiple projectssimultaneously is a must. Excellent written and verbal communication skills in English. Able to work in a team-oriented environment and work effectivelywith diverse departmental groups. Be self-motivated, able tointerface effectively with various levels, attentive to details andable to prioritize and meet deadlines, and must possess excellentleadership, problem solving, analytical, influencing and customerservice skills to operate and deliver results in a matrix-managedGMP environment. Computer literacy, independent understanding, follow and implementinstructions, work independently or as a team player andcollaborate with outside resources, and the ability to evaluateissues, make decisions and determine when to escalate, asnecessary. Candidate must possess outstanding attention to detail andorganization skills, effective decision-making skills, focus onprocess improvements, and ability to manage many complexassignments simultaneously.

Qualifications:

5 years of biopharmaceutical experience responsibility in quality,analytical development, process development, pharmaceutics,regulatory, or manufacturing environment. Understanding ofbiopharmaceutical bulk manufacturing and distribution processes.

General knowledge of cGMP and filing regulations, practices, andtrends pertaining to the manufacture, testing and distribution ofbiopharmaceuticals. The candidate must be self-motivated, able to interface effectivelyat various levels, have careful attention to details and anunderstanding that accuracy and precision in all aspects of workare necessary. Candidate must be able to prioritize and meetdeadlines, and must possess excellent leadership, problem solving,analytical, and customer service skills to operate and deliverresults in a matrix-managed GMP environment. Candidate must be well-organized, possess excellent oral andwritten communication skills, focus on process improvements,possess ability to manage many complex assignments simultaneously,and have the ability to function in a fast-paced environment.

Candidates must possess the ability to evaluate issues, makequality decisions and understand when to escalate, ifnecessary.

Basic Qualifications:

Doctorate degree OR master’s degree and 3 years of experience ORbachelor’s degree and 5 years of experience OR Associate degree and10 years of experience OR High school diploma / GED and 12 years ofexperience Top 3

Must Have Skill Sets:

Experience in GMP documents review and approval. General knowledgeof cGMP and filing regulations, practices, and trends pertaining tothe manufacture, testing and distribution ofbiopharmaceuticals. Candidate must be able to prioritize and meet deadlines, and mustpossess excellent leadership, problem solving, analytical, andcustomer service skills to operate and deliver results in amatrix-managed GMP environment. Document management experience

Pay Transparency:

The typical base pay for this role across theU.S.

is:

$30.00 – $33.00/hr. Final offer amounts, within the basepay set forth above, are determined by factors including yourrelevant skills, education and experience and the benefits packageyou select. Full-time employees are eligible to select fromdifferent benefits packages. Packages may include medical, dental,and vision benefits, 10 paid days off, 401(k) plan participation,commuter benefits and life and disability insurance. For information about our collection, use, and disclosure ofapplicant’s personal information as well as applicants’ rights overtheir personal information, please see our Privacy Policy(https://www.aditiconsulting.com/privacy policy). Aditi Consulting LLC uses AI technology to engage candidates duringthe sourcing process. AI technology is used to gather data only anddoes not replace human based decision making in employmentdecisions. By applying to this position, you agree to Aditi’s useof AI technology, including calls from an AI Voice Recruiter.