Senior Quality Assurance/Quality Control Specialist
The Senior QA/QC Specialist develops, establishes and maintains methodologies, systems and practices which meet the applicable regulatory requirements for Drugs and Biologics and 3DBio procedures as related to Quality Assurance and Quality Control. Serves as a Quality representative to improve awareness of the regulatory and 3DBio requirements to the different functional areas. Communicates quality initiatives in support of departmental, functional quality goals and priorities. Provides Quality support to the product development, manufacturing as related to test and process method development and validation as well as related equipment qualification.
This position will report to the Director of Quality and will will work closely with key stakeholders including Development, Manufacturing, Regulatory and external manufacturers.
Responsibilities to include:
- Champions Quality and cross functional Quality Assurance/Control initiatives.
- Administers the Quality Control process per established procedures that includes but it is not limited to Incoming inspection of materials.
- Provides Quality project support, coaching and mentoring to the R&D team.
- Provides guidance and support in generating product development documentation (product specifications, risk analysis, validation protocols, reports, etc).
- Generates documentation as related to test method validations and equipment qualification (SOPs and product specific documents).
- Proactively investigates, identifies and implements best-in class Quality practices.
- Identifies and implements effective quality systems to support of product development, qualification, and manufacturing of products in compliance with cGMP requirements.
- Leads and mentors the product development and manufacturing teams through the product development phase appropriate requirements.
- Ensures that all Quality requirements are met during the product development process.
- Assures the development and execution of systems which effectively identify and resolve quality issues.
- Assimilates relevant technical, regulatory, and compliance information to formulate suitable strategies and tactics to satisfactorily resolve complex problems.
- Bachelor Degree required; ASQ or RAPS certification is a plus.
- 5-8+ years of quality experience in the Biotech and/or Medical Device industry.
- Proven experience in improving and building Quality processes and systems to support biopharmaceutical and/or med device development.
- Strong knowledge of compliance best practices for drug, biologics and/or medical device products.
- Strong knowledge of US Quality System Regulatory requirements.
- Proven experience with implementation of Risk Analysis and related tools for product development.
- Experience with the development of Biologics, cell based therapies, and/or Advanced Technology Medicinal Products preferred.
- Results oriented: Ability to meet develop expectations and priorities, and meet clear goals. Flexible and creative problem-solving skills.
- Strategic Thinker: Can see the big picture, able to constantly think ahead about ways to do things better. Thinks logically, develops and evaluates options, identifies pros and cons. Able to challenge current processes, practices and strategy and uncover alternative approaches, solutions or methods.
- Peer leader: Proven track record of supporting, and preferably leading, high performance cross-functional teams. Experience delivering results in a small, fast paced organization.
- Communicator: Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill-sets to create, influence and negotiate win-win solutions.
- Strong interpersonal skills: Has the ability to motivate others, influence without authority, and navigate conflict situations. Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders.
- Self-directed: Individual who is able to work effectively with limited direction in a complex, fast-paced environment.