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Werfen · 1 day ago

Production Supervisor

US-GA-Norcross

Full-time

Onsite

Mid, Senior Level

2+ years exp

Werfen is a company focused on regulated manufacturing, and they are seeking a Production Supervisor for their VLPCC department. The Supervisor will ensure compliance with departmental procedures, maintain product quality, and support day-to-day manufacturing activities while leading and mentoring team members.

Health CareHospitalManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Ensure all VLPCC (Vialing, Labeling, Packaging and Controlled components) processing operations are performed accurately, efficiently, and in compliance with established SOPs, cGMP, and safety regulations

Lead, mentor, and support team members to meet daily production goals while promoting a culture of accountability, quality, and continuous improvement. Lead and assist in training and cross-training activities

Review, revise, and approve documentation, including manufacturing records, deviation reports, and quality control logs, to ensure data integrity and regulatory compliance. Assists with CAPAs, Change Controls, and Special projects/tasks as required

Monitor workflow and resource allocation to optimize efficiency and minimize downtime across shifts and operations

Serve as a first-line responder to operational issues, deviations, and product nonconformances, implementing corrective actions and escalating as needed

Collaborate cross-functionally with Quality, Supply Chain, Engineering, and other departments to ensure production timelines and quality expectations are met

Maintain accurate inventory levels, generate purchase requests, and ensure equipment and materials are available and operational to support processing activities

Track team and departmental performance using KPIs and quality metrics to identify trends, drive improvements, and meet organizational objectives

Support onboarding and cross-training efforts to build a flexible, knowledgeable, and resilient production team

Performs employee annual performance evaluations. Assists with cycle counts, maintains accurate inventory, and completes monthly and quarterly inventory

Lead triages for the department and initiate solutions to prevent reoccurring issues

Show the utmost commitment to Quality and Safety at all times

Performs other duties and responsibilities as assigned

Qualification

CGMP knowledgeFDA regulatory complianceSupervisory skillsLean Six SigmaProblem-solvingTime managementCommunication skillsAttention to detailBasic math skillsComputer literacyTeam-buildingEmployee development

Required

Bachelor's degree (BS/BA) from a four-year college, university, or equivalent combination of education and experience

2 years experience in a regulated manufacturing environment such as medical devices, pharmaceuticals, biotechnology, or blood banking

Demonstrated Managerial skills, including: planning and delegation, decision making and problem solving, budget management, performance management, conflict resolution, employee development and coaching

Strong understanding of cGMP, GDP, and FDA regulatory requirements within a manufacturing environment

2+ year minimum of previous supervisory and team-building skills with the ability to coach, motivate, and hold team members accountable

Knowledge of Lean Six Sigma or continuous improvement methodologies

Excellent organizational and time management abilities to coordinate multiple priorities under tight deadlines

Effective communication skills, both written and verbal, for cross-functional collaboration and documentation review

Competence in reading and interpreting SOPs, batch records, and regulatory documents

Ability to perform basic mathematical calculations, including percentages, ratios, and unit conversions

Proficient in problem-solving and root cause analysis to resolve manufacturing and quality-related issues

Capable of operating standard production equipment and performing aseptic techniques accurately

Strong attention to detail to ensure data accuracy, product integrity, and procedural compliance

Computer literacy with ability to navigate ERP systems and Microsoft Office applications (Word, Excel, Outlook)

Must be available to work irregular hours as necessary to meet production schedules with occasional overtime

Preferred

Aseptic technique and Aseptic gowning

Company

Werfen

Glassdoor4.0

Werfen is a developer, manufacturer and distributer of IVD testing solutions.

Founded in 1966

Barcelona, Catalonia, ESP

5001-10000 employees

http://www.werfen.com/

H1B Sponsorship

Werfen has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (10)

2024 (12)

2023 (10)

2022 (2)

2021 (11)

2020 (8)