Supply Chain Sr. Associate
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At a glance
Job overview
Spectraforce Technologies is hiring a Supply Chain Sr. Associate. The Supply Chain Sr. Associate will manage temperature excursions, minor and major deviations, CAPAs, and CAPA EVs within the US region. This role involves assisting with continuous improvement projects and GDP topics across the organization, collaborating with GD, Quality, IS organizations, and external vendors. The position reports to the Sr. Manager Supply Chain Compliance.
Key focus areas include Own and manage temperature excursion records., Own and manage minor and major deviation records and lead root cause analysis sessions., and Own and manage CAPA and CAPA EV records, ensuring they are implemented as intended..
Successful candidates bring High School Diploma/G.E.D., Bachelor's Degree Or Equivalent In Life Sciences, and 2 Years Experience In GMP / GDP Compliance. Important skills include GMP Compliance, GDP Compliance, Quality Assurance Principles, Good Manufacturing Practice, Good Distribution Practice, and Analytical Approach To Problems. Preferred (not required): Effective Communication Skills, Apply Risk-Based Approach, Making Decisions, and Escalating Issues Appropriately.
Skills & qualifications
Skills
Qualifications
Full job description
Experience Required
2 - 20 years
Minimum Education Required
High School Diploma/G.E.D.
Compensation
$7.25 / hourly
Hours Per Week
40
Number Of Positions
1
Work Schedule and Shift Requirements
First (Day)
Job Description
Job Title: Supply Chain Sr. Associate
Location: Louisville, KY 40299
Duration: 12 months (Extension possible)
Note:
Hybrid - 3 days Onsite (Tues, Wed, Thurs) and 2 days WFH
Standard hours
Top 3 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, Trackwise
Local candidate - either based nearby or about 1 hour away from the site.
Nice to have: Veeva, SAP
Ideal Candidate:
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.
Sr Associate Supply Chain Compliance
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.
Accountabilities
Embed the principles of Good Distribution Practices guideline in the US Supply Chain network, to ensure that product quality is maintained.
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.
Authority
Ability to apply risk-based approach, making decisions and escalating issues appropriately.
Outputs
Contribute to continuously improving the level of GDP compliance in the supply chain network.
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.
Fluency in English
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
Basic Qualifications
High school/GED + 2 years work experience OR? Associates and 6 months work experience OR? Bachelors
Top 3 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.
Possible Extension:
Yes
Red Flags:
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)
Interview Process:
2 rounds:
Phone screening
Onsite Panel interview (will take place at LDC)
SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of r ace, r eligion, color, s ex, national origin, age, s exual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at [email protected] if you require reasonable accommodation.
Job Type
Full time
Benefits Offered
Not specified
Veteran Preference
No
Place of Work
On-site
Requisition ID
6a4cdfcc-ef7d-43be-bdf1-842eda2b253a
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