- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …techniques, bioreactor operations, and cell line development + Strong knowledge of cGMP regulations and ICH guidelines relevant to upstream biologics manufacturing + ... Experience with a variety of expression systems (eg, CHO, HEK293, microbial) + Familiarity with Quality by Design (QbD) principles and their application to upstream processes + Excellent leadership skills with the ability to mentor and develop team members +… more
- PCI Pharma Services (Philadelphia, PA)
- …extra hours and/or weekend work. + Knowledge of and adherence to all PCI, cGMP , and GCP policies, procedures, rules. + Attendance to work is an essential function ... of this position **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with… more
- Biomat USA, Inc. (Williamsport, PA)
- …understanding of project requirements to ensure projects are in compliance with cGMP design, applicable codes, and environmental laws, rules, and regulations. **Job ... Responsibilities:** + Manage facility project design and construction by coordinating, reviewing, and administering the work of Architects, Engineers, Consultants, and Contractors. + Create cost management solutions for facility projects. Manage vendors,… more
- PCI Pharma Services (Philadelphia, PA)
- …require overtime and/or weekend work. + Knowledge of and adherence to all PCI, cGMP , and GCP policies, procedures, rules. + Attendance to work is an essential ... function of this position + Performs other duties as assigned by Manager/Supervisor. **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be… more
- ThermoFisher Scientific (Millersburg, PA)
- …production or lab setting or related field + Preferred: Experience in a cGMP environment **Knowledge, Skills, Abilities:** + Follow all safety protocols + Drive ... quality in all activities + Stand and move about including reaching, bending, stooping, grasping + Use hand tools and equipment including forceful gripping, grasping, pushing, and pulling **Physical Requirements / Work Environment** + Ability to work in a fast… more
- PCI Pharma Services (Philadelphia, PA)
- …such as engines, instruments, controls, robots, and machines. + Adhere to all PCI, cGMP , and GCP policies, procedures, and rules. + Perform other duties as assigned ... by the Senior Director of Operations. + Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to… more
- W. R. Grace (Tyrone, PA)
- …of standard operating procedures, quality improvement programs, risk management, and assurance of cGMP and compliance. You will be an integral member of the Quality ... Operations team and provide support to site leadership and customers. In addition, you will be the primary backup for the Plant Quality Assurance Manager, be a leader and mentor to junior staff members, and share industry best practices for implementing and… more
- Sanofi Group (Swiftwater, PA)
- …are validated in compliance with Sanofi's quality requirements and the applicable cGMP regulations. Providing quality oversight to the validation lifecycle (ie, from ... design to retirement) of computerized systems such as Computerized Systems (eg, environmental monitoring system [EMS], batch record management systems [MES], Data Historian, Process Control Systems (eg, distributed control system [DCS], programmable logic… more
- ThermoFisher Scientific (Millersburg, PA)
- …assuring/encouraging + Personally adhere to Safety Policy, Site and Company polices, QMS, CGMP , CGDP and assure/encourage the QCTs do likewise. + Display a strong ... work ethic and a desire to succeed and encourage the QCT's to do the same. **How will you get here** **Education:** + Minimum required education: Bachelor's degree (in a science or engineering related field preferred) **Experience** + 2+ years of prior… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …etc.) + Ensure US Allentown distribution warehouse is in compliance following CGMP -s + Handle/carry out other QA departmental activities/projects as assigned by the ... supervisor. Qualifications Education + BA/BS or equivalent work experience. Experience + Minimum 3 to 5 years of related experience in the pharmaceutical industry, specifically in QMS and Batch release. Knowledge and Skills + Excellent communication skills,… more