Production Supervisor

Werfen•Norcross, GA

About The Position

The Supervisor of VLPCC (Vialing, Labeling , Packaging and Controlled Components)is responsible for ensuring the consistent execution of departmental procedures, maintaining high standards of product quality, and supporting day-to-day manufacturing activities in compliance with cGMP, GDP, and safety standards. This position requires strong technical knowledge, leadership skills, and a commitment to continuous improvement in all facets of production. This position serves as the bridge between strategic leadership and hands-on execution, ensuring that every batch processed adheres to the highest regulatory, safety, and performance standards. Supervises the day-to-day activities in the Preproom, Packaging and Controlled Components areas to ensure conformance to department, company, and FDA guidelines and regulations. This position uniquely combines technical manufacturing knowledge, team leadership, and quality oversight to ensure that both people and processes are operating at peak performance.

Requirements

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.
Committed to excellence and high standards.
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.

Nice To Haves

Aseptic technique and Aseptic gowning.

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.