Paragon Bioservices, Inc. (PBI) is a growing biopharmaceutical contract development and manufacturing organization with an internationally recognized tradition of quality and service. PBI provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a PBI employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
This role is responsible for serving as a quality lead for Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption.
The Client QA contact serves as the dedicated Client QA Representative and liaisons with the Client and other Paragon functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit.
This position has the responsibility and authority to review and disposition GMP batches. Responsible for being involved in and providing disposition for failure investigations. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing.
Responsibilities include providing QA input to technology transfer documents, specifications, master/executed batch records, change requests, deviations and investigations.
Shift work and/or weekend work may be required at times.
DUTIES & RESPONSIBILITIES:
- Provides dedicated QA support to client projects and quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product used for human consumption.
- Primary QA contact during client project initiation until closure.
- Perform master and executed batch record reviews and disposition in an efficient and compliant manner to assure accuracy, completeness, and adherence. Assure that any events/non-conformances are properly investigated and explained.
- Review and evaluate Quality Control results for raw materials, intermediates, and finished product.
- Supports GMP departments in performing, and documenting deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and identifying/implementing effective corrective and preventive actions (CAPAs).
- Performs audits and supporting client project activities on the manufacturing floor. This includes, but not limited to: room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Also perform Acceptable Quality Limit (AQL) visual inspection of drug product, if applicable.
- Maintains databases and systems used for tracking various GMP manufacturing associated support activities.
- Assists with the generation and/or revision of GMP documentation such as Standard Operating Procedures.
- Support regulatory (i.e. FDA, EMA) and client audits/inspections of Paragon.
- Works cross-functionally with Project Management, Pre-Clinical Services, Manufacturing, Facilities, Quality Control and other departments to resolve quality issues and provide assistance when needed.
- Collaborate with other members of the QA Unit, including cross training where necessary, for performing duties and tasks in support of Paragons Quality Systems, such as review of validation master/executed protocols and reports.
- Support Pre-Clinical QA when needed during initial process development and non-clinical batch production. Primary responsibility to supportengineering runs, technology transfer and GMP manufacturing
- Identify compliance risks and quality process improvements to management with remediation proposal and lead solution implementation.
- Develop standard work practices to ensure high and consistent level of quality is maintained. Provide training in standard work specifics. Support, participate in, and approve compliance–critical efforts including change controls.
- Evaluate and perform compliance-related data trend analysis and report results. Make recommendations and drive implementation based upon findings.
- Track and evaluate any non-conformances that occur during the manufacture of drug product.
- Lead and participate in site quality and process improvement initiatives to ensure compliance and efficiency.
- Stay current with changes to current Good Manufacturing Practices, including FDA, EU, and other regulatory bodies (relevant to Paragon activities) and guidance bodies including ICH, ISPE, etc.
- Manage QA support for new product introductions at the site.
SKILLS & TECHNICAL EXPERTISE:
- Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, the USP AND ICH Guidelines. EU GMPs a plus.
- Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and/or fill/finish.
- Ability to function well under pressure in a changing environment.
- Creative individual with excellent analytical, problem solving, and decision-making skills.
- Ability to quickly learn new and novel manufacturing processes supporting new clients.
- Able to work in a team setting and independently under minimum supervision.
- Requires the ability to produce results in a fast-paced environment to meet client deadlines.
- Able to effectively interpret new and existing global regulations
- Able to communicate effectively with all levels of Paragon personnel and regulatory inspectors
- Familiarity with electronic systems, including developing and producing reports using Microsoft Access and Excel
- Experiencesupporting Federal government contracts a plus
- Work independently under minimal supervision to meet company goals
MEASUREMENT OF PERFORMANCE:
- Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
- Timeliness and accuracy in completion of projects and paperwork (quantity of work)
- Contributions to projects beyond general responsibilities (quality of work)
- Identification of problem areas affecting operations (knowledge/problem solving)
- Offers suggestions for correcting problems and for improving operations
- Exercises good judgment in dealing with operational problems
- Understanding of theory, rationale behind tasks performed
- Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs
- Ability to succeed in a team-oriented environment under very dynamic conditions
EDUCATION & PREVIOUS EXPERIENCE:
- Minimum of a B.S. in a Life Sciences discipline
- +8years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
- +4years’ experience in Quality Assurance/Quality Control function
- Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
- Familiarity with electronic systems, including Microsoft Access and Excel
- Experiencesupporting Federal government contracts is a plus