Website Aditi Consulting
Aditi Consulting
Company : Aditi Consulting
Payrate: $31.00 – $32.00/hr.
Summary:
The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at Company’s site. The position supports Clinical/Commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and facility events. Ideal candidates will have hands-on QA or manufacturing experience in a GMP environment (preferably within biotech) with strong critical thinking skills prioritized over academic credentials. A bachelor's degree in Biochemistry, Biology, Chemistry, or related scientific disciplines is preferred but not required.
Responsibilities:
- On the floor support giving PQA support for Manufacturing support. Record review and approval for BRRs, Deviations and SOPs.
- On the floor support giving PQA support for Manufacturing support. Record review and approval for BRRs, Deviations and SOPs.
- This position supports Company’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas.
- Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems.
- Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations .
- 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 for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
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.
- Also, ability to make Quality based decisions in order to ensure compliance.
- Experience managing projects through to completion & meeting timelines.
- Evaluating 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.
Desired Skills:
- Organizational skills
- Critical thinking ability
- Team player mindset
Pay Transparency: The typical base pay for this role across the U.S. is: $31.00 – $32.00 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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