Quality Assurance Senior Associate # 26-26617

Duration:12months contract

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.

Job Details:

• 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.

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

Day to Day Responsibilities:

• 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

Responsibilities Include the Following:

• 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

Preferred Qualifications:

• Bachelors 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

Basic Qualifications:

• High school/GED 4 years work experience or Associate 2 years work experience or Bachelor 6 months work experience or Masters 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 visit .

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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Required Experience:

Senior IC