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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Title:

Quality Assurance Specialist Sterile - Fill and Finish

Summary of Objective:

This full-time position will report to the Quality Manager - Sterile Fill Finish focusing on supporting the Quality department with review and release of executed batch records, product inspection, product or raw material release, document control, production monitoring, environmental monitoring, tracking quality metrics and assisting with validations, preventative actions, audits and continuous improvement. This position is responsible for performing quality activities within the Sterile Fill and Finish group in accordance with all applicable procedures, regulations, and safety directives. This individual’s primary job function will be review and release finished lots of drug product vials and syringes manufactured by PCI. Other job functions may be required at the discretion of management and include but are not limited to drafting procedures, sampling raw materials or finished products, assisting in general operations of the zero human intervention isolators all in accordance with GMPs and established SOPs

Essential Duties and Responsibilities:

• Perform product lot disposition by reviewing executed manufacturing batch records for completeness, accuracy, and compliance to GMP and company procedures.

• Perform document change control activities as needed.

• Perform and lead in investigations, NCMRs and complaints.

• Track and monitor CAPAs.

• Train new employees as needed.

• Support distribution and labeling activities.

• Collect quality metrics.

• Support the Sterile Fill and Finish Quality Manager with internal, supplier, regulatory and customer audits.

• Perform line clearances, in-process checks and monitoring of sterile manufacturing and finished product visual inspection.

• Perform finished product visual inspection or incoming release of incoming GMP materials according to appropriate material specifications.

• Ensure department and company goals are met.

• Reviews completed documentation and provided recommendations for process improvements to support existing procedures for continual improvement in conjunction with management.

• Capable of supporting sampling, packaging, and labeling operations.

• Performs GMP tasks by executing steps as written through established procedures with minimal supervision.

• Effectively communicates both verbally and in writing with all levels.

• Performs setup and operation of equipment such as Isolators, visual inspection light booth, and Biological Safety Cabinets.

• Performs all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.

Required Qualifications:

• Bachelor’s degree preferred and 1-2 years applicable work experience or a combination of education and years of applicable work experience.

• Basic Mathematical Skills

• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.

• Limited Working Proficiency: The ability to satisfy routine social demands and limited work requirements. The ability to read simple prose, in a form equivalent to typescript or printing, on subjects within a familiar context.

• Basic Reasoning: Ability to apply common sense understanding to carry out uninvolved written or oral instructions. Ability to deal with problems that involve only a few concrete variables in standardized situations.

Preferred:

• Ability to demonstrate attention to detail.

• Ability to display excellent time management skills.

• Ability to work independently and/or as part of a team.

• Experience in Sterile Fill and Finish CGMP environment.

• Experience in a cleanroom environment with PPE.

• Experience with visual inspection of drug products.

• Experience with CFR 210, 211 and 820, and EU Annex 1

• Experience working in an FDA regulated industry.

The base salary range for this position is $66,560 to $80,000 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise.

Equal Employment Opportunity/Veteran/Disabled

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled