Manufacturing Support Specialist
: Job Details :


Manufacturing Support Specialist

Orasure

Location: Bethlehem,PA, USA

Date: 2024-09-24T13:34:34Z

Job Description:

** Manufacturing Support Specialist**

** OraSure Technologies Bethlehem, Pennsylvania, United States (On-site)**

** Posted 1 week ago**

Full-time

Manufacturing

Medical Equipment Manufacturing

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OraSure Technologies Bethlehem, Pennsylvania, United States (On-site)

Manufacturing Support Specialist

OraSure Technologies Bethlehem, Pennsylvania, United States (On-site)

Manufacturing Support Specialist

OraSure Technologies Bethlehem, Pennsylvania, United States (On-site)

This company is an Equal Opportunity Employer. Please complete this information to assist us in complying with equal opportunity and/or affirmative action requirements, including recordkeeping and reporting requirements. Providing this information is voluntary. Refusal to provide this information will not result in any adverse treatment. Qualified applicants are considered for employment, and employees are treated during employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, national origin, ancestry, citizenship, age, physical or mental disability, legally protected medical condition or information, family care status, military caregiver status, veteran status, marital status, domestic partner status, sexual orientation, or any other basis protected by local, state, or federal laws. This company makes reasonable accommodations for disabled applicants and employees. This information form will be kept in a confidential file separate from your employment application. This company is an Equal Opportunity Employer. Please complete this information to assist us in complying with equal opportunity and/or affirmative action requirements, including recordkeeping and reporting requirements. Providing this information is voluntary. Refusal to provide this information will not result in any adverse treatment. Qualified applicants are considered for employment, and employees are treated during employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, national origin, ancestry, citizenship, age, physical or mental disability, legally protected medical condition or information, family care status, military caregiver status, veteran status, marital status, domestic partner status, sexual orientation, or any other basis protected by local, state, or federal laws. This company makes reasonable accommodations for disabled applicants and employees. This information form will be kept in a confidential file separate from your employment application.

+ A veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs.

+ A person who was discharged or released from active duty because of a service-connected disability.

Manufacturing Support Specialist

OraSure Technologies Bethlehem, Pennsylvania, United States (On-site)

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Manufacturing Support Specialist

OraSure Technologies Bethlehem, Pennsylvania, United States (On-site)

**Summary**

Perform OQ operations support functions. Review of executed BPRs, complete SAP transactions for labor hours and materials, update department metrics.

**Essential Responsibilities**

Review completed production BPRs for completeness and accuracy prior to QA Lot Release.

Complete SAP transactions for labor hours and materials.

Update metrics for presentation and distribution via department scorecards

Prepare quality documentation as needed (ie CTNs, PDRs, NCRs)

Assist operations team with preparation activities for customer/regulatory audits

Perform special assignments as apparent or assigned.

Plan, organize and monitor activities according to priorities.

Communicate and collaborate with management and supervisory staff within manufacturing and quality to achieve set goals.

Complete operations management area QA document review requirements for procedures for the following:

Annual Review of Documents

Training compliance

CAPA due dates

**Education and Experience**

Three to five years of working experience in a related work environment.

Experience in GMP/ISO FDA regulated medical device facility.

Previous Manufacturing experience in an FDA regulated environment.

The individual must have a working knowledge of the medical diagnostic industry and compliance regulations.

***OraSure and its subsidiaries is committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.***

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