Quality Assurance Specialist (GMP, Document management)

Description:

Fully onsite

Standard business hours

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.

FUNCTIONS

1. 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. 2. Candidate will also be responsible for working with other Client departments. 3. 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. Doctorate degree OR Master's degree & 3 years of experience directly related to the job OR Bachelor's degree & 5 years of experience directly related to the job

COMPETENCIES/SKILLS

? Strong project management skills, experience working in cross-functional teams, and the ability to handle multiple projects simultaneously is a must. ? Excellent written and verbal communication skills in English.? Able to work in a team-oriented environment and work effectively with diverse departmental groups. Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment. ? Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.? Candidate must possess outstanding attention to detail and organization skills, effective decision making skills, focus on process improvements, and ability to manage a large number of complex assignments simultaneously.

OTHER PREFERRED QUALIFICATIONS

? 5 years of biopharmaceutical experience responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment. Understanding of biopharmaceutical bulk manufacturing and distribution processes. General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.? The candidate must be self-motivated, able to interface effectively with various levels, have careful attention to details and an understanding that accuracy and precision in all aspects of work are necessary. Candidate must be able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, and customer service skills to operate and deliver results in a matrix-managed GMP environment.? Candidate must be well-organized, possess excellent oral and written communication skills, focus on process improvements, possess ability to manage a large number of complex assignments simultaneously, and have the ability to function in a fast paced environment. Candidate must possess the ability to evaluate issues, make quality decisions and understand when to escalate, if necessary.?

Basic Qualifications

Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience

Top 3 Must Have Skill Sets:

• Experience in GMP documents review and approval. General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals. Candidate must be able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, and customer service skills to operate and deliver results in a matrix-managed GMP environment.
• Document management experience

Day to Day Responsibilities:

• 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.