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MCS Senior Associate Quality Assurance

Aditi Consulting

Thousand Oaks, California, United States, CA

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JOB DETAILS
SALARY
$30–$32 Per Hour
SKILLS
Artificial Intelligence (AI), Automotive Automation, Biochemistry, Biology, Business Solutions, Chemistry, Cleanroom, Clinical Support, Communication Skills, Consulting, Detail Oriented, Documentation, Drug Products, Establish Priorities, Facilities Engineering, GMP (Good Manufacturing Practices), Health Plan Membership, Hospital, Insurance, Leadership, Maintain Compliance, Manufacturing, Messaging Technology, Multitasking, Operational Audit, Organizational Skills, Presentation/Verbal Skills, Process Improvement, Project Execution, Project/Program Management, Purchasing/Procurement, Quality Assurance, Reimbursement, Short Messaging Service (SMS), Speech Technology, Standard Operating Procedures (SOP), State Laws and Regulations, Systems Analysis, Team Player, Telephony, Time Management, Writing Skills
LOCATION
Thousand Oaks, California, United States, CA
POSTED
21 days ago
Payrate: $30.00 - $32.00/hr.
 
Summary:
The Specialist Business Systems Analyst will be a key member of the program team working towards the This role involves providing real-time, floor-based QA support at Company site, with a rotation between day and swing shifts every six months. 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, with strong critical thinking skills prioritized over academic credentials.
 
Responsibilities:
  • Provide support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff.
  • Maintain a purposeful presence on the floor for real-time QA support.
  • Conduct electronic batch record review and approve SOP revisions and work orders.
  • Provide quality approval of minor deviations and evaluate compliance issues.
  • Represent the Drug Substance Quality Assurance department in project execution to achieve operational goals.
 
Qualifications:
  • Hands-on QA or manufacturing experience in a GMP environment.
  • Bachelor's Degree in Biochemistry, Biology, Chemistry, or related scientific disciplines preferred but not required.
  • Experience managing projects through to completion and meeting timelines.
  • Evaluating documentation and operations according to company procedures.
  • Experience working with Quality Systems.
  • Strong critical thinking skills.
  • Attention to detail.
  • Quality background.
 
Desired Skills:
  • Ability to perform GMP operations, follow detailed SOPs, and maintain good documentation practices.
  • Strong organizational skills and ability to manage multiple tasks at one time.
  • Effective communication skills (both written and verbal).
  • Ability to work as both a team player and independently.
  • Display leadership attributes and drive improvement initiatives.
 
Pay Transparency: The typical base pay for this role across the U.S. is: $30.00 - $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. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting

privacy@aditiconsulting.com

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Aditi Consulting

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