Specialist Manufacturing

Summary of Role: 

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
 

Responsibilities:

Applied Process Expertise

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Process Monitoring

• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.

Non-Conformance and CAPA

• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation

• Assist with generation of process validation protocols and reports.
• Assist with the execution of the process validation.
• Support collection and analysis of process validation data.

Regulatory

• May participate in regulatory inspections

New Product Introductions & Process or Equipment Modifications

• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• 2. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control

• Assist manufacturing change owner on CCRB packages impacting the process.

Projects and Initiatives

• Participate on the assessment or implementation of special projects or initiatives.

Shift: Administrative 

Location: Juncos, PR 
 

Education:

Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate’s degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.

Preferred background: Science or Industrial Engineering

Preferred Qualifications: 

•  Work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Project Management and/or Quality Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English, with ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
• Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
• Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, or Vevaa or a comparable quality system
• Experience navigating and executing transaction in SAP (ERP) system.
• Ability to tactfully negotiate and positively influence peers and executive leadership.
• Strong negotiation skills when working with external suppliers and internal team members.
• Ability to maintain remote working relationships with colleagues and Amgen network.

Skills:

• Detailed technical understanding of bioprocessing unit operations.
• Skilled in performance of GMP production operations.
• Regulatory knowledge and interactions.
• Participate and help lead cross-functional teams.
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
• Organizational, technical writing and presentation skills.
• Basic project management skills.
• Basic knowledge of control charting.

This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Full time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: Echo Consulting Group Inc