Senior Quality Assurance Associate

Aditi Consulting; Holly Springs (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Aditi Consulting is looking for a Quality Assurance Associate in Holly Springs, NC, to oversee quality practices in accordance with GMP regulations. This role involves ensuring compliance throughout the manufacturing and testing processes while maintaining precise documentation. Ideal candidates should have experience in a regulated environment and strong communication skills.

Benefits

Medical, dental, and vision benefits

401(k) plan participation

10 paid days off

Commuter benefits

Qualifications

• Experience in a cGMP manufacturing facility or a highly regulated environment.
• Strong knowledge of GMP and GDP Behaviors.
• Ability to work as a team player and independently.

Responsibilities

• Provide ongoing Quality oversight to ensure compliance with cGMP.
• Drive closure and completion of cGMP processes and documents.
• Oversee manufacturing processes and analytical testing.

Skills

Knowledge of process and facility equipment

Ability to interpret and apply Good Manufacturing Practices

Strong communication skills

Tools

Electronic Quality Systems

Job description

1 week ago Be among the first 25 applicants

• 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 production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
• 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), change control records and validations
• Oversee and provide guidance during on-the-floor manufacturing process and analytical testing
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.

Payrate: $28.30 - $30.36/ hr.

Responsibilities:

• 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 production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements
• 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), change control records and validations
• Oversee and provide guidance during on-the-floor manufacturing process and analytical testing
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.

Skills:

• Knowledge of process and facility equipment, ability to interpret and apply Good Manufacturing Practices (GMP); quality assurance or manufacturing experience in the pharmaceutical or medical device industry; written and spoken fluency required.
• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment. Strong GMP and GDP Behaviors.
• Knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems, experience with minor deviations
• Demonstrated ability to work as a team player and independently. Strong communication skills and ability to complete assignments and meet timelines.

Top 3 Must Have Skill Sets:

• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment. Strong GMP and GDP Behaviors.
• Knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems, experience with deviations
• Demonstrated ability to work as a team player and independently. Strong communication skills and ability to complete assignments and meet timelines.

Pay Transparency: The typical base pay for this role across the U.S. is: $28.30 - $30.36/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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 (https://www.aditiconsulting.com/privacy-policy).

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi’s use of AI technology including calls from an AI Voice Recruiter.

#AditiConsulting

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

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