Job Description:
Texwipe, an ITW Company, is
the worldwide leader in contamination control supplies & critical cleaning products. For over 50 years, Texwipe has been committed to manufacturing products such as cleanroom wipers, swabs, and stationery, sterile products, adhesive mats, and so much more! We are consistently growing and looking to add team members to our dynamic environment who are looking to make a global impact. With global headquarters in Kernersville, North Carolina, the company has a global presence with sales offices throughout North America, Europe, and Asia. In addition, Texwipe's manufacturing centers throughout North Carolina, the Philippines, and China provide the highest levels of quality and manufacturing technology. Working for Texwipe means you will have a lasting impact on critical industries across the world.
The organization's commitment to
technology, innovation, & service excellence provides the most consistent and highest quality products for its customers. Texwipe also pledges to provide
fairness and transparency, fair and consistent treatment, & development opportunities. Texwipe promises to be an organization that stands by its commitments to its customers and employees, improving and growing into the future.
Job Description
In this role, the Sterile Product Analyst is responsible for the following:
- Comply with ANSI/ AAMI/ ISO 11137 guidelines for sterile product validation and routine monitoring.
- Coordinate irradiation doses; review and approve ASNs for sterile lots prior to product transfer to irradiator.
- Coordinate sample collection/ retention for Burst, Dose, Validation, LAL, and Bioburden testing with QA.
- Work with the Materials Manager to coordinate the weekly production schedule to reduce sterile product testing costs.
- Arrange testing by an approved lab to meet all AAMI, ISO, and SOP requirements.
- Analyze and maintain test reports/ records, control invoicing and provide cost reports per management’s request.
- Review certificate of irradiation daily and make all necessary database entries. Ensure availability of finished product certifications on the company website. File all records according to SOP’s.
- Review sterile batch records (including label reconciliation) and auditor first piece records for accuracy/ completion to maintain documentation controls.
- Assist in writing/ updating relevant SOPs, work instructions, and test methods where needed for Sterile Product Testing.
- Provide sterile product technical support for supplier/ customer audits and for management meetings.
- Provide Texwipe certifications for both sterile and non-sterile products upon request by the customer support team.
- Oversee in-house LAL testing and training.
- Serve as a lead for coordination of lab WIP samples and ordering lab supplies
- Ensure there is an adequate supply of press plates for the departmental quarterly cleanings.
- Occasional travel to other locations, including customer sites.
- Requires working a flexible work schedule on short notice, as needed.
- Perform special projects and other duties as required
Job Qualifications:
- Associates degree and at least 1-year related experience/and or training or equivalent combination of education and experience.
- Strong computer skills including Microsoft Word, PowerPoint, Excel, and Outlook.
- Excellent organizational, planning, and time management skills, and the ability to prioritize tasks when there are multiple and conflicting demands. Must be able to meet deadlines.
- Must be detail-orientated, highly accurate, and dependable.
- Strong verbal and written communication skills in English; with the ability to correspond via electronic and written communications.
- Ability to work independently and as part of a team.
- Ability to effectively lead and communicate positively with managers and employees at all levels of the organization.
- Ability to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals.
- Ability to calculate figures and amounts such as percentage, area, concentration, and volume.
- Must be comfortable working in a blended office and manufacturing environment.
- Must be able to don appropriate gowning materials and wear PPE as defined by plant safety procedures.
- Ability to draw conclusions and justify decisions.
- Must be able to frequently stand, sit, walk, reach, kneel, and lift, move, or transport up to 40lbs.
What can Texwipe offer you? See below!
- Robust training program and career development opportunities
- 3 - for 1 company gift match program
- Tuition reimbursement
- Multiple health plan options along with dental, vision, and life insurance.
- FSA, HSA, and DCA options
- Onsite health clinics
- Wellness resources & discounted employee health premiums
- Employer-paid STD/LTD & AD&D benefits
- Paid parental leave
- 10 paid company holidays and 2 floating employee choice holidays
- 401(K) plan with generous company match & so much more
All your information will be kept confidential according to EEO guidelines.
ITW is an equal opportunity employer. We value our colleagues’ unique perspectives, experiences and ideas and create workplaces where everyone can develop their careers and perform to their full potential.
As an equal employment opportunity employer, ITW is committed to equal employment opportunity and fair treatment for employees, beginning with the hiring process and continuing through all aspects of the employment relationship.
All qualified applicants will receive consideration for employment without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, protected Veteran status or any other characteristic protected by applicable federal, state, or local laws.
