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Senior Quality Assurance Associate
Aditi Consulting
- 🇺🇸 United States
- On-site
- Senior
- 6 hours ago
- $24.00 – $25.50 / hour
- GMP
- Outlook
- Excel
- PowerPoint
- AI
- Pension
6 hours ago
Summary:
In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
Responsibilities:
- Provide Quality oversight for Manufacturing operations to ensure that products are manufactured, tested, stored, and distributed according to current applicable regulations.
- Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
- Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
- Ensure that deviations from established procedures are documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Alert management of quality, compliance, supply and safety risks.
- Complete required assigned training to permit execution of required tasks.
- Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.
- Communicating and collaborating with the PQA shift to ensure required tasks are completed
Qualifications:
- Bachelor’s degree and 2 years of Quality/Manufacturing work experience
- Experience working in a cGMP environment
- Experience with decision making
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
- Knowledge of data integrity requirements
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
- Experience collaborating within and across functional areas and demonstrated customer service focus
- Excellent written and verbal communication skills
- Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
Top Must Have Skill Sets:
- GMP experience is a must, Independent but able to work within a team structure,
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams),
- Knowledge of Good documentation practices and data integrity requirements,
- Excellent written and verbal communication skills.
Pay Transparency: The typical base pay for this role across the U.S. is: $24.00 - $25.50/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.
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Senior Quality Assurance Associate · Aditi Consulting