Aditi Consulting
Senior Associate Quality Assurance
Aditi Consulting, Thousand Oaks, California, United States, 91362
Summary
The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor‑based QA support at our facility in Thousand Oaks, CA. This fully onsite role involves rotating between day and swing shifts every six months, beginning on day shift for training. The position supports 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 or a similar setting) with strong critical‑thinking skills prioritized over academic credentials. Responsibilities
Provide daily oversight of the Drug Substance manufacturing areas as part of the Plant QA organization. Support and enforce compliance oversight to Manufacturing and Facilities & Engineering areas/staff in executing their processes, procedures, and quality systems. Maintain purposeful presence on the floor, perform electronic batch record reviews, revise & approve SOPs, approve work orders, and provide quality approval for minor deviations. Evaluate compliance issues, provide recommendations, and ensure progress of quality records to completion. Represent the functional area for the Drug Substance Quality Assurance department in executing projects necessary to achieve departmental operational goals and work in a 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 records, and good documentation practices. Ability to make quality‑based decisions to ensure compliance. Experience managing projects through completion and meeting timelines. Experience evaluating documentation and operations according to company procedures. Experience with Quality Systems, strong organizational skills, and ability to manage multiple tasks concurrently; effective written and verbal communication skills. 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 $30.00 - $32.00/hour. Non‑exempt positions are eligible for overtime at 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, which may include medical, dental, and vision benefits; health savings accounts; paid time off; bereavement leave; retirement plan participation with employer match; life and disability insurance; commuter benefits; dependent‑care flexible spending account; accident, critical illness, and hospital indemnity insurance; accommodations and reimbursement for work travel; and discretionary performance or recognition bonuses. Sick leave and mobile phone reimbursement are 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, 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 other related 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, texts, 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. 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. Seniority level
Entry level Employment type
Contract Job function
Quality Assurance Referrals increase your chances of interviewing at Aditi Consulting by 2x.
#J-18808-Ljbffr
The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor‑based QA support at our facility in Thousand Oaks, CA. This fully onsite role involves rotating between day and swing shifts every six months, beginning on day shift for training. The position supports 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 or a similar setting) with strong critical‑thinking skills prioritized over academic credentials. Responsibilities
Provide daily oversight of the Drug Substance manufacturing areas as part of the Plant QA organization. Support and enforce compliance oversight to Manufacturing and Facilities & Engineering areas/staff in executing their processes, procedures, and quality systems. Maintain purposeful presence on the floor, perform electronic batch record reviews, revise & approve SOPs, approve work orders, and provide quality approval for minor deviations. Evaluate compliance issues, provide recommendations, and ensure progress of quality records to completion. Represent the functional area for the Drug Substance Quality Assurance department in executing projects necessary to achieve departmental operational goals and work in a 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 records, and good documentation practices. Ability to make quality‑based decisions to ensure compliance. Experience managing projects through completion and meeting timelines. Experience evaluating documentation and operations according to company procedures. Experience with Quality Systems, strong organizational skills, and ability to manage multiple tasks concurrently; effective written and verbal communication skills. 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 $30.00 - $32.00/hour. Non‑exempt positions are eligible for overtime at 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, which may include medical, dental, and vision benefits; health savings accounts; paid time off; bereavement leave; retirement plan participation with employer match; life and disability insurance; commuter benefits; dependent‑care flexible spending account; accident, critical illness, and hospital indemnity insurance; accommodations and reimbursement for work travel; and discretionary performance or recognition bonuses. Sick leave and mobile phone reimbursement are 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, 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 other related 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, texts, 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. 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. Seniority level
Entry level Employment type
Contract Job function
Quality Assurance Referrals increase your chances of interviewing at Aditi Consulting by 2x.
#J-18808-Ljbffr