Aditi Consulting
Plant Quality Assurance (PQA) Associate
Base Pay Range:
$30.00 - $32.00/hr
Summary:
In this critical role, you will serve as a Plant Quality Assurance (PQA) professional, providing on‑floor quality oversight for Facilities and Engineering (F&E), Process Development, Incoming Quality Assurance (IQA), and Manufacturing operations. This position requires close collaboration with cross‑functional teams to ensure that all activities within bulk drug substance operations adhere to cGMP and other regulatory requirements.
Responsibilities
Provide quality oversight for F&E, IQA Warehouse areas (including Incoming Inspections and the Raw Material Sampling Lab), and Process Development Laboratories.
Ensure facilities, equipment, materials, processes, and products comply with cGMP standards and other applicable regulatory requirements.
Review and approve work orders and job plans within Maximo.
Review logbooks (paper‑based and electronic), particle‑generating forms, pest control sighting forms, periodic pest control reports, RT reports, and other GMP documentation.
Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs.
Handle rejected materials.
Review and approve Delta V Audit Trail entries.
Document deviations from established procedures according to approved processes.
Communicate and collaborate effectively across departments (PQA, PD, IQA, F&E, and Manufacturing) to ensure completion of assigned tasks.
Complete required training assignments to maintain compliance and readiness for task execution.
Proactively identify and elevate quality, compliance, or safety risks to management.
Maintain a presence in cleanroom areas (≈25% of shift time), including proper gowning and adherence to aseptic practices.
Preferred Qualifications
Bachelor’s Degree in a relevant field (e.g., Life Sciences).
Minimum of 2 years of experience in Quality or Manufacturing, with exposure to F&E‑related activities.
Strong understanding of cGMP principles and regulatory expectations.
Experience with enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) to support quality oversight, documentation management, and manufacturing execution processes.
Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Teams).
Excellent written and verbal communication skills.
Experience collaborating within and across functional areas, with a strong focus on customer service and partnership.
Demonstrated ability to make sound decisions in a dynamic, fast‑paced environment.
Ability to prioritize and navigate ambiguity with minimal oversight.
Must Have Skills
Prioritization and navigation of ambiguity with minimal oversight in a fast‑paced environment.
Exposure to F&E operations and documentation (paper‑based and electronic).
GMP experience (MFG, Quality, or F&E).
Sensitivity & Eligibility Seniority Level: Entry level
Employment Type: Contract
Job Function: Quality Assurance
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.
Benefits & Additional Information 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; 401(k) plan participation with employer match; life and disability insurance; commuter benefits; flexible spending accounts; accident insurance; critical illness insurance; hospital indemnity insurance; accommodations; work travel reimbursement; 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 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. 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.
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$30.00 - $32.00/hr
Summary:
In this critical role, you will serve as a Plant Quality Assurance (PQA) professional, providing on‑floor quality oversight for Facilities and Engineering (F&E), Process Development, Incoming Quality Assurance (IQA), and Manufacturing operations. This position requires close collaboration with cross‑functional teams to ensure that all activities within bulk drug substance operations adhere to cGMP and other regulatory requirements.
Responsibilities
Provide quality oversight for F&E, IQA Warehouse areas (including Incoming Inspections and the Raw Material Sampling Lab), and Process Development Laboratories.
Ensure facilities, equipment, materials, processes, and products comply with cGMP standards and other applicable regulatory requirements.
Review and approve work orders and job plans within Maximo.
Review logbooks (paper‑based and electronic), particle‑generating forms, pest control sighting forms, periodic pest control reports, RT reports, and other GMP documentation.
Review and approve Manufacturing Execution System (MES) records, including EBRs and ESPs.
Handle rejected materials.
Review and approve Delta V Audit Trail entries.
Document deviations from established procedures according to approved processes.
Communicate and collaborate effectively across departments (PQA, PD, IQA, F&E, and Manufacturing) to ensure completion of assigned tasks.
Complete required training assignments to maintain compliance and readiness for task execution.
Proactively identify and elevate quality, compliance, or safety risks to management.
Maintain a presence in cleanroom areas (≈25% of shift time), including proper gowning and adherence to aseptic practices.
Preferred Qualifications
Bachelor’s Degree in a relevant field (e.g., Life Sciences).
Minimum of 2 years of experience in Quality or Manufacturing, with exposure to F&E‑related activities.
Strong understanding of cGMP principles and regulatory expectations.
Experience with enterprise systems such as Maximo, OEFM, MES, and Veeva Vault (CDOCS/DQMS) to support quality oversight, documentation management, and manufacturing execution processes.
Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Teams).
Excellent written and verbal communication skills.
Experience collaborating within and across functional areas, with a strong focus on customer service and partnership.
Demonstrated ability to make sound decisions in a dynamic, fast‑paced environment.
Ability to prioritize and navigate ambiguity with minimal oversight.
Must Have Skills
Prioritization and navigation of ambiguity with minimal oversight in a fast‑paced environment.
Exposure to F&E operations and documentation (paper‑based and electronic).
GMP experience (MFG, Quality, or F&E).
Sensitivity & Eligibility Seniority Level: Entry level
Employment Type: Contract
Job Function: Quality Assurance
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.
Benefits & Additional Information 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; 401(k) plan participation with employer match; life and disability insurance; commuter benefits; flexible spending accounts; accident insurance; critical illness insurance; hospital indemnity insurance; accommodations; work travel reimbursement; 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 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. 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.
#J-18808-Ljbffr