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Quality Assurance Senior Associate # 26-26617
US Tech Solutions, Inc.
- 🇺🇸 United States
- On-site
- Senior
- 6 hours ago
- $26.00 – $27.84 / hour
- GMP
- Outlook
- Excel
- PowerPoint
- AI
6 hours ago
Job Description:
- This position works a rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:45 AM – 7:00 PM ***
- Ideal Candidate: 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 data integrity requirements, Excellent written and verbal communication skills.
- 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.
- cGMP experience
- Experience collaborating within and across functional areas and demonstrated customer service focus
- Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
- Quality Oversight (including Purposeful Prescence on the Floor) of bulk drug substance manufacturing operations
- GMP documentation review/approval (including EURs, electronic logbooks, RT reports, Work Orders, batch records, etc.)
- Interim and reject cage management
- 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
- 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
- High school/GED + 4 years’ work experience or Associate + 2 years’ work experience or Bachelor + 6 months’ work experience or Master’s Degree
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visitwww.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement:By applying, you acknowledge that AI-assisted tools may be used during hiring.
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Quality Assurance Senior Associate # 26-26617 · US Tech Solutions, Inc.