Quality Assurance Specialist

Job Title:

Supply Chain Sr. Associate (Qualtiy Assurance)

Location:

Louisville, KY 40299 Duration: 12 months (Extension possible)

Note:

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

• 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, Trackwise
• Local candidate — either based nearby or about 1 hour away from the site.
• Nice to have:
  Veeva, SAP

Bachelors + 2 years of working experience. Labatory skills, quality background would be beneficial, detail oriented, multitasking, teamwork, and strong communication.

Technical skills:
Smartsheet, Excel, PowerPoint, Trackwise, Veeva, SAP.

Nice to have: previous pharma experience.

We are looking for a Supply Chain 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 with 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.

• 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.

• 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.

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

• Experience in audit / inspection support
• Technical writing skills
• 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 with a high degree of discipline and attention to detail

High school/GED + 2 years work experience OR? Associates and 6 months work experience OR? Bachelors

• 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

• 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 smart sheets for minor, major, CTETS and missing products.
• Own and support continuous improvement initiatives

Yes

• This concerns a remote position but the candidate needs to work on site (LDC) for 3 days a week.
• Job offer - cannot stay in a company for a long time(more than 1 year)

• Phone screening
• Onsite Panel interview (will take place at LDC)

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.