Sr. Quality Assurance Associate

$28.00-$29.99 per hour

Louisville, KY

Contract

Duration : 12 months contract

Hybrid - 3 days Onsite (Tues, Wed, Thurs) and 2 days WFH

Summary:

• We are looking for a professional to own and manage temperature excursions, minor and major deviations, CAPA's and CAPA EV's that are reported in the US region and to assist in various projects related to continuous improvements and GDP topics across the organization. Parties involved are the GD organization, Quality organizations, IS organization and external vendors.

• The position will report into the Sr. Manager Supply Chain Compliance.

• Embed the principles of Good Distribution Practices guideline in the US Supply Chain network, to ensure that product quality is maintained.

• Ability to apply risk-based approach, making decisions and escalating issues appropriately

• Contribute to continuously improving the level of GDP compliance in the supply chain network.

• Ideal Candidate : Bachelors + 2 years of working experience. Laboratory skills, quality background would be beneficial, detail oriented, multitasking, teamwork, and strong communication. Technical skills: Smartsheet, Excel, PowerPoint, trek wise, Veeva, SAP.

• Nice to have previous pharma experience.

Qualifications Minimum Requirements:

• Bachelor's degree or equivalent in Life Sciences + 2 years' experience in GMP / GDP compliance

• In the absence of a Life Sciences degree, 4+ years' experience in GMP / GDP compliance

• Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.

• Strong word processing, database and spreadsheet application skills and experience in Quality Management Software systems (e.g. Trackwise, EDMQ, etc)

Preferred Requirements:

• Experience in audit / inspection support

• Technical writing skills

Competencies:

• Effective communication skills at multiple levels, areas and countries

• Ability to apply risk-based approach, making decisions and escalating issues appropriately

• Analytical and evidence-based approach to problems.

• Ability to see the connection between issues, to identify common factors and bring the correct stakeholders together.

• Pro-active in proposing solutions and driving tasks to completion

• Works autonomously, respecting deadlines

• Works with a high degree of discipline and attention to detail

Must Have Skill Sets:

• Bachelor's degree or equivalent in Life Sciences + 2 years' experience in GMP / GDP compliance

• Sound knowledge of Quality Assurance principles, Good Manufacturing Practice and Good Distribution Practice.

• Analytical and evidence-based approach to problems.

• Technical writing skills: Smartsheet, Excel, PowerPoint, trek wise

• Local candidate - either based nearby or about 1 hour away from the site.

• Nice to have : Veeva, SAP

Day to Day Responsibilities:

• Own and manage temperature excursion records.

• Own and manage minor and major deviation records and lead root cause analysis sessions.

• Own and manage CAPA and CAPA EV records, ensuring that they are implemented as intended.

• Manage missing product notifications, including leading Event Review Team meetings if applicable.

• Support audits and inspections.

• Ensure up to date smartsheets for minor, major, CTETS and missing products

• Own and support continuous improvement initiatives.

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.

IND01

#LI-AS140