Quality Assurance Specialist

PSC Biotech • York, PA

13d

About The Position

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill -finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill -finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs. The Experience With operations spanning the globe and featuring a multi -cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At BioTechnique, it’s about more than just a job—it’s about your career and your future. Your Role We are hiring an experienced and adaptable Quality Assurance Specialist to join BioTechnique. The QA Specialist plays a critical role in driving successful completion of operational tasks, performing quality reviews, and providing guidance to various departments to ensure adherence to regulatory requirements and industry best practices. This role also requires experience in safety programs, including acting as a safety officer and participating in internal or OSHA -related safety audits.

Requirements

• Bachelor’s degree in sciences, engineering, or related discipline.
• 4 -5 years of experience in a Quality role within the life sciences industry.
• At least one year of experience managing projects and priorities within complex matrix organizations.
• Advanced knowledge of relevant regulations (FDA, cGMP, OSHA).
• Experience with safety programs and audits (internal and OSHA).
• Proficient in using quality management tools and software.
• Demonstrated ability to execute strategic and tactical objectives provided by senior leaders.
• Experience with regulatory inspections and interactions with regulatory agencies.
• Strong analytical and problem -solving skills with keen attention to detail.
• Excellent communication and interpersonal skills; ability to work effectively in a team -oriented environment.
• Independent decision -making capability and ability to understand the impact of decisions.
• Strong organizational and project management skills; ability to manage multiple projects and timelines.
• Effective leadership skills.

Responsibilities

• Provide QA support to GMP areas including:
• Critical utilities (e.g., WFI, Steam, Automation, equipment, HVAC)
• Warehouse operations
• Manufacturing processes
• Inspection, labeling, and packaging
• Batch record review and disposition
• New product introduction and product transfer
• External quality and laboratories
• Support tactical QA operations by assessing and reviewing floor activities against cGMPs for real -time observation, issue identification/resolution, and proper documentation.
• Ensure adherence to SOPs, change control, CAPA/deviation management, risk management, and compliance with FDA/EU regulatory standards.
• Provide guidance to GMP areas (Manufacturing, QC, etc.) to ensure compliance with all applicable regulations.
• Oversee change management system for minor and major classified change controls.
• Identify, classify, and report deviations; support remediation and CAPA activities.
• Ensure timely closure of investigations and resolution of issues before process release.
• Collaborate with cross -functional teams to determine root cause and implement preventative/corrective actions.
• Perform technical review of documentation during and post -execution of cGMP activities.
• Communicate with clients, vendors, and external services to resolve investigations and ensure compliance.
• Participate in inspection readiness activities and regulatory inspections.
• Support safety programs and audits.
• Additional duties as required.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level