Quality Inspector

West Pharmaceutical Services / Progressive Medical; Kinston (NC); Sur place; USD 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Generous PTO

Bonuses

Global career opportunities

Professional development

Résumé du poste

West Pharmaceutical Services is seeking a Quality Specialist to ensure in-process and finished goods meet quality standards and documentation requirements. This onsite role supports product development and batch-record activities in a regulated environment.

The ideal candidate has a HS diploma or GED with 2+ years in QA/QC, preferably in medical devices or pharmaceuticals, and skills in MasterControl, SAP/ERP, and MS Office. Shift is a 12-hour night rotation; relocation is not provided.

Qualifications

• High school diploma or GED required; Bachelor's degree preferred in a related field.
• At least 2+ years in regulated QA/QC, preferably in medical devices or pharmaceuticals.
• Experience with document control and quality systems (GDP/ISO) is essential.

Responsabilités

• Perform sampling, inspections, and testing of in-process and finished goods per procedures and AQL plans.
• Release acceptable products for further processing or shipping; maintain batch records.
• Review inspection records and ensure proper documentation practices; manage nonconforming material handling.
• Generate deviation and rejection reports; support traceability and records disposition.

Connaissances

Quality Assurance

Documentation Control

Microsoft Office

SAP ERP

Formation

Bachelor's degree preferred

HS diploma or GED

Outils

MasterControl

SharePoint

Excel

Description du poste

This is an onsite position requiring the team member to be onsite for all scheduled workdays.

No relocation assistance is provided for this opportunity.

Shift Hours: 12-hour Nights on 2, 2, 3 Rotation

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World war 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

This role is essential in ensuring customer specifications and timelines are met and is accountable for in-process quality control services and support. The Quality Specialist role will be responsible for materials acceptance activities, provide additional quality inspection, quality control testing, sampling inspection and documentation control activities within the Quality team. Adhering to Good Documentation Process (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records. The Quality Specialist will handle projects and tasks in support of product development and will play an active role to ensure products meet quality standards consistent with internal procedures and acceptance criteria, while meeting company and regulatory requirements.

Essential Duties And Responsibilities

• Perform sampling, inspections, and testing of in-process and finished goods products per applicable procedures and AQL plans, utilizing both visual means as well as calibrated test equipment to include laser micrometer, optical comparator and other equipment as applicable.
• Release acceptable in-process and finished goods product for further processing and/or shipping as applicable per site.
• Understand and follow applicable ISO standards requirements.
• Perform review of inspection records to assure product conforms to specifications and proper documentation practices.
• Retains sample of finished products and maintains all applicable documents to form batch records and ensures appropriate batch records disposition (i.e. filing, scanning etc.) as necessary.
• Print documents from Master Control, shopfloor or other software program and manages documents related to the Quality System.
• Segregate nonconforming product and handle quarantined product and raw materials as applicable by site.
• Generate rejection and deviation reports as directed by site.
• Perform trace back investigation of nonconforming raw material and product as directed by site.
• Promotes and supports a Lean environment.
• Conforms with and abides by all corporate and site-specific regulations, policies, work procedures, instruction, and all safety rules.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned.

Education

• High school diploma or GED required.
• Bachelor's degree, vocational or technical training or degree with emphasis in Quality Control preferred.

Work Experience

• No minimum required.
• A minimum of 2+ years of experience in regulated Quality Assurance/Quality Control preferred.
• A minimum of 2+ years of experience in medical devices or pharmaceuticals industry preferred.

Preferred Knowledge, Skills And Abilities

• Ability to work independently, multi-task and thrive in a fast-paced environment.
• Experience with managing Document Control activities within a regulated industry.
• Excellent written and verbal communication skills.
• Proficient in Windows OS, Microsoft Office Suite including Word, Excel, and PowerPoint.
• Familiarity with Master Control, SAP/ERP system and SharePoint.
• Must have effective problem solving and interpersonal skills.

Travel Requirements

None: No travel required

Physical Requirements

Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.

Additional Requirements

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception and the ability to adjust focus.
• Ability to perform basic mathematical tasks like counting, adding, subtracting, and rounding and to record, balance and check for accuracy.
• Effectively communicate and interface with various levels internally and with customers.

What We Offer

• Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
• Recognition & Rewards: Performance-based bonuses, service recognition, and employee appreciation initiatives celebrate dedication and impact.
• Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where all voices are heard and respected in a supportive environment.
• Continuous Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and skill-certification initiatives.
• Global Career Opportunities: With facilities across North America, Europe, and Asia-Pacific, employees have opportunities for international exposure and cross-functional collaboration.
• Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.

No relocation is provided for this opportunity

This is an onsite position requiring the team member to be onsite 5 days per week

Sponsorship is not provided for this opportunity

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to [e-mail] . Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening.