Senior Quality Assurance Specialist - US Tech Solutions : Job Details

Job Details

Job Title: Quality Assurance Sr. Associate

Location: West Greenwich, RI

Duration: 12 months of contract

NOTE: This position works a rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday | Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:50 AM – 7:00 PM

Job 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. Ideal Candidate must have GMP experience, drive, 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.

Responsibilities Include the Following:

• Provide Quality oversight to ensure that operations 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
• 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

Preferred 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 3 Must Have Skill Sets:

• 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

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 visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,

national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Shalini L

Email: [email protected]

Internal ID: 24-25061