What are the responsibilities and job description for the MCS Senior Associate Quality Assurance position at Aditi Consulting?
Payrate: $ 30.00- $ 31.00/hr.
Summary:
The Sr. Associate Quality Assurance position supports Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities and Engineering staff in the execution of their processes, procedures, and use of quality systems.
Duties include but are not limited to:
Preferred Qualifications:
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
Responsibilities will include:
Pay Transparency:
The typical base pay for this role across the U.S. is: $ 30.00- $ 31.00/hr.. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different 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 of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.
#AditiConsulting
Summary:
The Sr. Associate Quality Assurance position supports Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities and Engineering staff in the execution of their processes, procedures, and use of quality systems.
Duties include but are not limited to:
- Purposeful presence on the manufacturing floor, inc. Inspection support, ASP and QA assessments,
- Electronic batch record review,
- SOP revision approval,
- Maximo System - Work order, job plan approvals,
- Quality support and approval of minor deviations and CAPA records.
- MES revisions and approvals
Preferred Qualifications:
- Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
- Experience managing projects through to completion meeting timelines.
- Ability to evaluate documentation and operations according to company procedures.
- Experience working with Quality Systems
- Strong organizational skills and ability to manage multiple tasks at one time
- Effective communication skills (both written and verbal)
- Demonstrated ability to work as both a team player and independently
- Display leadership attributes and drive improvement initiatives
- Solid understanding and application of aseptic behaviors and principles
Top 3 Must Have Skill Sets:
- Detail Oriented
- Team player
- Quality Assurance Experience.
Day to Day Responsibilities:
- Duties include but are not limited to:
- Purposeful presence on the manufacturing floor, inc. Inspection support, ASP and QA assessments,
- Electronic batch record review,
- SOP revision approval,
- Maximo System - Work order, job plan approvals,
- Quality support and approval of minor deviations and CAPA records.
- MES revisions and approvals
Responsibilities will include:
- Evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
- The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
Pay Transparency:
The typical base pay for this role across the U.S. is: $ 30.00- $ 31.00/hr.. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different 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 of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.
#AditiConsulting
Salary : $30 - $31
