This position is responsible for managing and coordinating QA efforts in multiple areas of the company. This position shall also implement strategies and procedures that are intended to comply with regulations governing pharmaceutical products as part of a quality program. The QA Manager will oversee cleanroom and sterile manufacturing compliance to include; PAIs, FDA Interactions, Lot Release, Validations, Training, Doc Control, Batch Records, CAPA, OOS, CMC Submissions Sections and other compliance needs for the company.

Position responsibilities:

• Oversees the development, implementation, and maintenance of quality assurance systems and activities including but not limited to document control, commissioning, training, materials control, investigations, supplier qualification, compliance, CAPA, and batch record review/lot release
• Coordinates and ensures training on validation equipment and materials and documentation requirements in good manufacturing practices
• Coordinates and ensures that cleanrooms, their equipment, materials, layout and documentation meet good manufacturing practices
• Responsible for training employees within and outside of the department to assure up-to-date knowledge of practices and procedures of Quality Assurance
• Oversees qualification and validation plans for cleanrooms, and systems, cleaning, and process activities associated with the manufacturing of biotherapeutic and biopharmaceutical products in aseptic environments
• Assures that facilities, laboratory equipment, utility systems, and process equipment are validated and calibrated and that reports are properly written
• Creates appropriate corrective action plans to prevent or correct deficiencies
• Participates in FDA inspections, audits and other QA tasks
• Evaluates internal compliance with current standard operating procedures
• Approves validation protocols and reports
• Directs the development and implementation of validation test procedures to ensure products meet validation requirements
• Drafts initial templates and revises templates as required

The qualified candidate will have:

• Bachelor degree in life science, engineering or other related discipline
• 5 to 7 years experience with QA in an cGMP, FDA regulated manufacturing environment
• 5+ years in aseptic, sterile based environment with strong cleanroom and contamination knowledge, biopharmaceuticals and/ or biotherapeutics (injectable) is ideal
• Prior experience with the QA component of design and build of cleanrooms is ideal
• Experience with FDA site Pre-Approval Inspections (PAI) is required
• Experience in leading teams and outside vendors
• Expert knowledge in cGMP requirements
• Experienced with cleanroom pharmaceutical manufacturing
• Ability to make decisions and recommendations
• Experience with the following; document control, commissioning, training, materials control, investigations, supplier qualification, compliance, CAPA, and batch record review and lot release

Industry: Quality Assurance, QA, cleanrooms, sterile pharmaceuticals, PAI, biotherapeutics, document control, commissioning, training, materials control, investigations, supplier qualification, compliance, CAPA, and batch record review, lot release

Job Code: 406-32-MH2322

Location: Texas, relocation is available

Apply directly at: http://www.maxhire.net/cp/?E55E6A361D43515B7D52182B77501E6C482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

The Line Supervisor’s purpose and function is to coordinate the activities of production employees and continuously improves the process directed towards customer satisfaction and profitability, ensuring food safe, high quality products are produced that meet or exceed all regulatory or legal requirements. The line supervisor is also responsible for maintaining a safe work environment for all employees.

Responsibilities include:

• Coordinates the training of employees to fully understand the responsibilities and duties to meet customer and regulatory requirements
• Ensures all operators remain current in their job training and that all employees attend all safety training classes
• Maintains awareness of production schedule and ensures line employees are aware of customer expectations for quality and food safety
• Ensures accurate and timely data gathering for customer and regulatory requirements. Ensures data is used to make timely corrections to the process, as needed, to address any product deficiencies
• Actively reviews computer output to ensure appropriate levels and quality of production
• Counsels and/or disciplines employees, as needed
• Keeps accurate records of employee counseling and follows up on all disciplinary issues
• Ensure good communication throughout the department and the plant. Promotes teamwork and leads project teams

The qualified candidate will have:

• Minimum 3 years of supervisory experience or minimum of 2 years as an internal equipment operator
• Prior poultry, RTE production experience is ideal
• Good oral and written communication skills
• Proven ability to work on a team
• Ability to work line machinery as necessary

Industry: Food production, fully cooked, poultry, Tyson, ConAgra, pilgrims pride, Perdue, chicken, second shift, line supervisor, leadership, RTE

Job Code: 423-32-MH2322

Location: Birmingham

Apply directly to: http://www.maxhire.net/cp/?E55E69361D43515B7D52182B77501C69482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

This position is responsible for responsibility for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program. Will provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities, work with the CAPA team and participate as an active member on new product development teams.

The qualified candidate will have:

• BS or higher level of degree in engineering or science
• 5+ years experience with companywide validation needs, 10 years is ideal in medical devices or other FDA regulated industry
• Experience developing and executing IQ, OQ and PQ protocols for product, processes, facilities, software, cleaning and equipment
• Strong FDA, cGMP and ISO knowledge and quality program management
• Must have project management experience (PM)
• Experience and knowledge in continuous improvement methods required
• Knowledge and ability with FMEA and risk analysis

• Ability to read and understand blue prints and technical drawings
• Strong communications skills both written and oral
• Experience with SPC, CAPA, DOE is a plus
• High level of proficiency with MS Office, Minitab, and working with databases

Industry: Validation, IQ, OQ, PQ, Engineering, equipment, cleaning, methods validation, quality systems, San Diego, CAPA, FMEA, Risk Analysis, ISO, Continuous Improvement,  medical device, IVD, project management, PM

Job Code: 411-32-MH2322

Location: San Diego

Apply directly at: http://www.maxhire.net/cp/?E55E6E361D43515B7D52182B77501F6B482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

The Medical Laboratory IT Systems Analyst will oversee the prioritization, planning, operational and maintenance functions of the Lab Systems and other assigned projects.

The qualified candidate will have:

• AS Degree minim in science or computer science, ideal is a BS in Science or a BS/MS in Information Systems and Computer Programming
• MT / HTL ASCP certified medical lab professional OR 5 to 7 years experience in laboratory systems management
• Cerner Command Language (CCL) and Oracle databases is preferred
• Must be able to communicate effectively with the medical lab team, senior leaderships and other IT personnel
• Experience with pathology laboratory information or working in a pathology lab
• Experience with microcomputers, multiple vendors and locations and multiple operating systems is ideal
• Well developed, verbal, written and customer service skills

Industry: MT, HTL, ASCP, Med Lab, Alaska, laboratory systems, IT, CCL, Oracle, IT, LIS, pathology

Job Code: 417-32-MH2322

Location: Alaska

Apply directly to: http://www.maxhire.net/cp/?E55E64361D43515B7D52182B77501F6D482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com ) 910-338-2795

This position is responsible for managing and coordinating the execution of design for the facility layouts and will perform various engineering functions with the manufacturing team.

The qualified candidate will have:

• Bachelor degree in architectural engineering, mechanical engineering or other related engineering disciplines
• 3+ years experience with manufacturing, ideal is in pharmaceutical or biotech facilities
• Experience with AutoCAD and Revit
• Knowledge and ability to read and utilize blue prints
• Ability to make decisions and recommendations
• Strong communications skills both written and oral
• High level of proficiency with MS Office and internet research

Industry: Design Engineer, Drafting, AutoCAD, CAD, Revit, Engineering, Manufacturing, Facility Design, Pharmaceuticals

Job Code: 422-32-MH2322

Location: Texas, relocation assistance is available

Apply directly at: http://www.maxhire.net/cp/?E55E68361D43515B7D52182B77501C68482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com) 910-338-2795

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The qualified candidate will have:

• Bachelor or Masters Degree with a current CPM/CPSM certification is a plus
• 3+ years of experience in procurement
• Ideal category or spend with cabinetry, tables, chairs, signage and other furniture and equipment
• Experience with interfacing with distributors / vendors
• Strong oral and written communication, organizational
• Well versed in MS Office and Outlook
• Strong negotiation skills and the ability to work in a team environment across functional responsibilities
• Able to manage and measure financial performance

Industry: Buyer, category management, procurement, vendor management, negotiation, furniture, signage, fixtures

Job Code: 416-32-MH2322

Location: North Carolina

Apply directly at: http://www.maxhire.net/cp/?E55E6B361D43515B7D52182B77501F6C482D7D

The Wellington Group ( http://www.twgrecruiters.com)   910-338-2795

The Vice President is responsible for contract negotiations for the purchase of goods for distribution and commodities for manufacturing to individual retail, wholesale and partners.  This includes commodities, packaging, equipment, uniforms, and other supply items.  The overall strategy will be to maintain constant supply globally without experiencing any large unfavorable pricing changes, while looking for all opportunities to reduce inventory investment. In addition, helping to put into place best practices, new standards and developing tangible and measurable operational metrics.

The qualified candidate will have:

• 4-year degree required, MBA is a plus
• Ten years experience in senior management procurement or purchasing role, minimum of 3 years experience in global procurement at a Senior Director or VP level
• Food Service, Nutriceuticals, QSR or other food / beverage industry experience is a plus
• Knowledge of the commodity supply markets and international pricing and procurement
• Ability to work in a team environment across functional responsibilities with experience in managing and developing people
• Ideal candidate has experience working with Asia and the Middle East
• Very strong analytical skills with attention to detail
• Excellent technology skills applied to the management of both internal and external data
• Capable of financial skills to manage and measure the purchasing to scheduling, planning, budgeting and other functional activities
• Understanding of accounting and cost principles and working knowledge of all business related processes (Operations, Logistics, Finances, Information Systems, Human Resources)

Industry: Food Service, Beverage, QSR, Procurement, Purchasing, Global Sourcing, International Procurement, Vendor Management, Strategic Sourcing, Asia, Middle East

Job Code: 415-32-MH2322

Location: North Carolina

Apply directly at: http://www.maxhire.net/cp/?E55E6A361D43515B7D52182B77501F6F482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com ) 910-338-2795

The Designer – Drafter will be responsible for the design and drafting of all new orders, both custom and standard equipment produced.  Will work with the sales department and engineering teams to produce drawing for customers and help troubleshoot design issues for customer developed drawings or previously built equipment.

Primary responsibilities include:

• Design and draft to scale producing accurate and timely shop drawings
• Responsible for inspecting all assigned customer orders for details
• Enter product information and specifications into manufacturing software
• Assist customers by phone or in person to help troubleshoot issues
• Responsible for prioritizing the drafting and design of orders based on quotes
• Assist the shop mechanics with production problems
• Utilize manufacturing software to create bills of material for products
• Provide purchasing with accurate information to order required non-stocked components

The qualified candidate will have:

• Degree or equivalent work experience in engineering is ideal, BS or MS in Mechanical Engineering is preferred
• AutoCAD, Solidworks, Inventor skills and experience required
• Strong computer skills and ability to pick up new techniques and software quickly
• Working knowledge of sheet metal and structural steel a plus
• Ability to produce, read, and understand shop drawings
• Capable of working independently and with little supervision
• Ability to interface with sales, engineers, designers and customers

Industry: Engineering, Design, AutoCAD, CAD, Solidworks, Inventor, Thermodynamics, Mechanical Engineer, Drafting, Steel

Job Code: 414-32-MH2322

Location: North Carolina

Apply directly at: http://www.maxhire.net/cp/?E55E69361D43515B7D52182B77501F6E482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com ) 910-338-2795

The Sales Engineer is responsible for managing and supporting the customers from following up on leads and inquires to defining needs, facility and systems design, submitting conceptual drawings and final product completion/delivery. This role will be the point person for technical questions and the liaison with the client and internal staff members to resolve any changes or challenges in the development process. Overall customer project manager and technical support lead for the company.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence.

The qualified candidate will have:

• 5+ years experience pharmaceutical and biologics work experience, especially design and engineering of related facilities or processes
• Bachelor’s Degree in Engineering or related life science discipline, MBA or MS is a plus
• Experience working with sales leads through product design and customer support for final project deliverables
• Strong customer service skills and a track record or handling customer inquiries, complaints and presentations both internally and externally
• Knowledge of clean rooms, aseptic manufacturing and sterile fill
• Training and experience in FDA and cGMP compliance and regulations for pharmaceutical and biotech products
• Commissioning and validation knowledge is key for success in this role
• Proven experience in design transfer to manufacturing
• AutoCAD or 3-D design knowledge, submitting conceptual drawings, and blueprint reading and presentations is ideal
• Ideally seeking experience in solutions selling for customizable pharmaceutical or biological process or facility solutions

Industry: Sales Engineer, pharmaceutical facility deign, AutoCAD, customer support, project management, GMP, FDA, cleanroom, sterile, aseptic, biologics, technical liaison, conceptual drawings

Job Code: 413-32-MH2322

Location: Texas

Apply directly at: http://www.maxhire.net/cp/?E55E68361D43515B7D52182B77501F69482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com ) 910-338-2795

The R&D Culinary Professional is responsible for supporting the continuous development of new products that include calendar/seasonal/promotional products, new product concepts for both food and variations of hot and cold beverage offerings.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence.

The qualified candidate will have:

• 3+ years experience culinary experience with new product innovations, Pastry Chef is ideal
• Degree in Food Science or Culinary from a recognized food or culinary institution
• Proven experience with pastries and baked goods
• Ideally seeking hot and cold beverage product experience
• Strong knowledge and experience with product prototypes and testing of products that align with the brand
• Strong written and oral communication skills, able to present ideas and new concepts
• Able to work in a team-based environment with other key leaders throughout the organization
• Corporate and career minded, self-driven professional
• Strong computer skills

Industry: Culinary, Pastry Chef, Pastry, product innovation, beverage, Chef, Food, Product R&D, Menu Items, Hot and Cold

Job Code: 412-32-MH2322

Apply directly at: http://www.maxhire.net/cp/?E55E6F361D43515B7D52182B77501F68482D7D

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com ) 910-338-2795