Quality Assurance Senior Associate

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. 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.

Payrate: $24.00 - $26.00/hr.

Summary
We are seeking a Plant Quality Assurance (PQA) professional to provide on-the-floor quality oversight in support of manufacturing activities within a cGMP-regulated environment. This position requires close collaboration with Manufacturing personnel during bulk drug substance operations to support real-time quality decisions, ensure compliance with applicable regulations, and maintain high standards of product quality and data integrity.
This is a 100% onsite position. 

Responsibilities

• Provide quality oversight to ensure products are manufactured, tested, stored, and distributed in accordance with current regulations and quality requirements.
• Support manufacturing operations through on-the-floor quality presence and real-time decision-making.
• Ensure facilities, equipment, materials, processes, procedures, and products comply with cGMP requirements and other applicable regulations.
• Review and approve cGMP-related processes, procedures, documentation, and records.
• Review GMP documentation, including logbooks, batch records, work orders, reports, and supporting attachments.
• Ensure deviations from established procedures are properly documented and managed according to approved procedures.
• Verify that production records and testing results are complete, accurate, and documented in accordance with written procedures and cGMP requirements.
• Identify and communicate quality, compliance, supply, and safety risks to management.
• Complete all assigned training required to perform job responsibilities.
• Perform duties within cleanroom environments for the majority of each shift, including required gowning procedures.
• Collaborate and communicate effectively with PQA shift team members to ensure required tasks are completed.
• Support interim material management and reject cage management activities.
• Review and approve GMP documentation, including electronic records and manufacturing documentation.

Requirements
Education Requirements

• Bachelor’s degree in a scientific discipline or a related field preferred.

Experience Requirements

• Minimum of 2 years of Quality Assurance, Quality Control, Manufacturing, or related experience preferred.
• Experience working in a cGMP-regulated environment.
• Experience reviewing batch records and GMP documentation.
• Experience making quality-related decisions in a manufacturing environment.
• Experience collaborating across multiple functional areas.
• Experience supporting manufacturing operations in a fast-paced environment.

Required Skills

• Strong knowledge of cGMP regulations and quality compliance requirements.
• Knowledge of good documentation practices and data integrity requirements.
• Ability to provide quality oversight within manufacturing operations.
• Strong attention to detail when reviewing GMP documentation and records.
• Proficiency in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and MS Teams.
• Excellent written and verbal communication skills.
• Ability to work independently while contributing effectively within a team environment.
• Strong organizational and prioritization skills.
• Ability to navigate ambiguity with minimal oversight.
• Demonstrated customer service focus and cross-functional collaboration skills.
• Ability to identify, escalate, and communicate risks appropriately.

Preferred Skills

• Experience working with bulk drug substance manufacturing operations.
• Experience with analytical testing and/or general compendia testing.
• Familiarity with electronic logbooks, reports, work orders, and manufacturing records.
• Strong decision-making skills in a regulated manufacturing environment.
• Experience working within cleanroom environments.
• Ability to adapt to changing priorities while maintaining compliance and quality standards.
• Proven ability to function effectively in a team-oriented environment while managing individual responsibilities.

Pay Transparency: The typical base pay for this role across the U.S. is: $24.00 - $26.00 /hr. 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.

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