Think Different. Do Different. Be Different.
Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.
The Manager, Technical Operations Visual Inspection is accountable for driving results in a fast-paced environment by managing all tasks vital to establish and monitor the Visual Inspection programs across Alcami two sterile manufacturing sites (Charleston, SC & Morrisville, NC), and assuring compliance to industry standards. This position will support the hiring and training of the visual inspection teams at both locations.
This person will be responsible for managing the visual inspection programs and assure the visual inspection team’s compliance to Alcami and industry standards. The Manager is accountable for developing and maintaining Standard Operating Procedures (SOP) and driving the compliance, training and development and continuous improvement of the teams. In addition to overseeing the Visual Inspection program, this hands-on leader should have functional capability to perform the essential functions and activities alongside the visual inspection manufacturing associates. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
- Responsible for the management and oversight of the Visual Inspection programs at Alcami. This includes, developing program strategy and procedures to assure that the program meets both Alcami’s and industry standards.
- Supports site customer and Regulatory audits from a Visual Inspection perspective.
- Builds and maintains qualification kits to support Visual Inspection program across the company.
- Partners with Quality and other internal groups to establish a philosophy for visual inspection and visual inspection qualification for the Manufacturing operators and QA team members.
- Responsible for building the training/qualification curriculum for the Visual Inspection program for the Manufacturing and QA teams.
- Collaborates with Manufacturing and Quality teams to develop the program for classification of rejects and AQL levels.
- Analyze, and trends rejects and AQL defects rates and provides metrics and presents KPIs to management team.
- Participates in equipment design, and startup of VI equipment for both manual/semi- manual visual inspection start up and supports implementation/qualification of semi-manual inspection process.
- Develops and reviews all SOPs, policies, work instructions, batch records, etc. regarding visual inspection, defects, rejects, and defect kits.
- Effectively and clearly communicates across functions, collaborating with Manufacturing, Quality and the customer to write/review/approve visual inspection deviations, change controls, CAPAs, etc.
- Supports in the reviews and approval process of generated data from visual inspection.
- Accountable for the performance and results to industry standards.
- Leads internal investigations and works cross-functionally with other departments toward solutions.
- Performs duties in accordance with Standard Operating Procedures (SOPs).
- Troubleshoots technical issues within the visual inspection process.
Education and Experience
- Bachelor’s degree preferred.
- 5 years of related work experience required
- cGMP experience required; prior pharmaceutical or CDMO experience preferred.
- Consistently demonstrates honesty and integrity through personal example.
- Follows all safety policies and leads by example a safety-first culture.
- Produces high quality work product with a focus on first time right.
- Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies
- Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
- Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
- Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
- Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
- Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
- Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.
- Knowledge of cGMP, SOPs, CAPAs, manufacturing, finished goods inspection and inventory management required.
- Knowledge of Visual Inspection requirements for injectable products.
- Knowledge of reviewing batch records, Lean Manufacturing, pharmaceuticals, and investigations/event processes.
- Excellent communications, problem solving, organizational skills, time management and ability to handle confidential documents required.
- Knowledge of basic computer skills, including Microsoft office and windows-based system required.
- Directly supervises team of direct reports.
- Participates in the hiring process of other employees.
- Makes hiring decisions of other employees.
- Schedules and reviews the work of other employees.
- Ensures accuracy and relevance of assigned training curriculum.
- Drives timely completion of training for employees to meet regulatory requirements.
- Coaches, mentors and develops other employees.
- Prepares and delivers performance evaluations of other employees.
- Makes recommendation of disciplinary actions of other employees.
Decision Making and Supervision Required
- Uses professional concepts and company policies and SOPs to solve a variety of problems.
- Receives general instructions on routine work, detailed instructions on new projects or assignments.
- Up to 50% domestic travel between North Carolina and South Carolina manufacturing sites