Quality Assurance Manager - York, United States - PSC Biotech

PSC Biotech York, United States

1 week ago

Description

The work we do at BioTechnique has never been more important—and we are looking for talented candidates to join us.

We're growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives.

Join BioTechnique and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

Here, you'll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We're proud to cultivate a culture that will fuel your passion, energy, and drive. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At BioTechnique, you determine what's possible.

BioTechnique is a highly potent sterile injectable and clinical oncolytics manufacturing company dedicated to providing cytotoxic and high potency sterile injectable fill-finish services.

BioTechnique's project management and client services staff work closely with our clients to meet all manufacturing needs.

From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and optional lyophilization services for a wide variety of liquid injectables.

BioTechnique utilizes our team's expertise to work with our clients to create a process design for their product that suits their needs.

Your Role
The Quality Assurance Manager will provide leadership and guidance to our Quality department and oversee operational tasks.

The QA Manager is responsible for managing the QA/QC tasks required for day-to-day operations, management of quality events by working with cross-functional teams, providing on the-floor quality support, guidance on quality standards, and mentor junior team members.

The individual is to ensure high quality of products, staff, budget, and goals for the Quality department.

The ideal candidate should demonstrate effective leadership skills, and possess a strong background in pharmaceutical and aseptic and sterile manufacturing, clean room environments, and quality testing.

Works independently to provide leadership and QA oversight of any area of the business responsible for adhering to current Good Manufacturing Practices (cGMPs) including:
Critical utilities (e.g. WFI, Steam, Automation, equipment, HVAC, etc.)
Warehouse
Manufacturing Processes
Inspection
Labeling and Packaging
Batch Record Review
Batch Disposition
New Product Introduction and Product Transfer
External Quality and Laboratories

Responsible for both executing the tactical operations and overseeing junior team members as they assess, evaluate, and review operations on the floor (as defined above) against current Good Manufacturing Practices (cGMPs) to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation.

Provides guidance to all GMP areas (i.e., Manufacturing, Quality Control, etc.) to ensure compliance with all applicable regulations and assists in resolution of issues identified.

Information must be pro-actively shared across QA and the business including the on-going training of junior team members.
Performs independent technical review of documentation during and post-execution of cGMP activities.
Signs off/qualifies/trains junior staff on QA/QC Operation/Validation responsibilities.
Ensures all specifications are met and that applicable requirements are completed and acceptable.

Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.

Analyzes and reports findings to appropriate departments.

Works closely with others in the assigned area to recognize opportunities for improvement and drive change through the use of Quality Systems.

Serves as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and hosts inspections by regulatory agencies or clients. Maintains the approved supplier list.

Utilize a wealth of previous experience, provides a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes.

Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans (CAPA)/Deviation management, impact assessments for changes to equipment and processes, risk management, and to ensure documentation and investigations meet BIFI and regulatory standards.

Implements continuous improvement efforts as it relates to QA activities.
Indirectly leads others within the QA/QC/Validation/Warehouse Teams under the leadership of the area head.
Fosters quality collaboration among the site and QA staff.
Identifies, classifies and reports deviations, as appropriate and typically works on complex Major deviations and/or complaints. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions. Ensures support for the timely closure of investigations.
Authorized to suspend any operation when the situation warrants. Provides guidance and control directives regarding remediation activities required to continue production. Is required to resolve critical issues utilizing independent judgement and decision making as a senior level of the department. May serve as the final decision-maker in situations requiring the input of others to make a final compliance determination.

May also be required to communicate with clients, external vendors, external services to resolve investigations as warranted to ensure compliance to regulations and local procedures.

Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.

This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.

Sought after by junior team members for guidance in the quality oversight of changes within the Quality Management System including appropriate stakeholders reviews are completed such as Regulatory, Client, Area Managers, etc.

Models effective and constructive communication behaviors and interactions with technical departments, junior team members and senior business leaders, both orally and in writing; maintain acceptable proficiency in technical and non-technical (e.g., interpersonal) skills.

Is proficient in technical and non-technical (e.g., interpersonal) skills to ensure the continued success of the department and quality of oversight provided to the business.

Creates and establishes processes and procedures to ensure compliance and adherence to regulated QA activities for cGMP operations.
Mentors, trains and coaches new personnel as required and supports the development and implementation of training programs. Available to act as a resource for colleagues with less experience regardless of level.
May work on external client projects as a consultant, as needed.
Other duties as required.
Requirements
Bachelor's or higher degree from an accredited four-year university, preferably in sciences or engineering.
7+ years of quality experience within the pharmaceutical and aseptic and sterile manufacturing environment.
At least 3 years of leadership experience managing projects and priorities within complex matrix organizations.
Strong knowledge of clean room environments and ISO requirements.
Sterile manufacturing experience is preferred.
Microbiology background is a plus.
Knowledge of aseptic and sterilization techniques.
Ability to execute strategic and tactical objectives provided by senior leaders across functional departments.
Strong independent judgment and decision-making abilities.
Experience leading teams and driving project success.
Advanced knowledge of relevant regulations and guidance is required in order to be an effective resource for colleagues.
Proven project-management skills required. Must be able to manage multiple projects against given timelines.
Demonstrated strong and productive work ethic.
Proven global problem-detection and problem-resolution skills required.
Possesses strong conflict resolution and negotiation skills.
Excellent organizational and time management skills.
Effective verbal and written communication skills; great interpersonal skills.
Ability to collaborate across teams with diverse views effectively or backgrounds.
Benefits

Offering a full suite of benefits, PSC BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success.

We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

Medical, Dental, and Vision - BioTechnique pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts

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