Quality Assurance Senior Associate

Sr Associate PQA

The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance.

Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations.

Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.

Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA)s.

Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.

Oversee and provide guidance during on-the-floor analytical testing.

Ensure that changes that could potentially impact product quality are assessed according to procedures.

Ensure that deviations from established procedures are investigated and documented per procedures.

Alert senior management of quality, compliance, supply and safety risks.

Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.

Identification and implementation of continuous improvement opportunities within our processes and systems.

Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.

Top 3 Must Have Skill Sets:

• PQA/Mfg Operations experience
• Worked in a GMP Facility
• Teamwork
• Fast Learner and ready to contribute

The typical base pay for this role across the U.S. is: $30.00 - $32.00 /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.

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 View email address on click.appcast.io . 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 #AditiConsulting