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Planet Pharma
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Quality Assurance Specialist
Posted: 04/29/2025
2025-04-29
2025-06-11
Employment Type:
Contract
Job Category: Technology
Job Number: 619319
Is job remote?: No
Country: United States
Job Description
Target PR Range: 26-36/hr
*Depending on experience
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 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.?
*Depending on experience
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 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.?
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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