Quality Assurance Specialist

PharmaBlock (USA) Inc, located in Hatfield, PA, is a subsidiary of PharmaBlock Science (Nanjing), a fast growing and leading fine chemical and CDMO company that has been providing products and services to global pharmaceuticals companies since 2008. Over the past years, PharmaBlock has collaborated with over 80% of the top 20 pharmaceutical companies, and hundreds of small to medium-sized biotechs around the world. Our core values are equality, dedication, innovation and fulfillment.

Currently we are seeking a Quality Assurance Specialist, who is motivated, eager to learn and grow their professional career with our company.

Educational Qualifications:

· BS preferred in a scientific discipline e.g. Biology, Chemistry, Biochemistry, etc.

Required Experience:

· Minimum 3 years of relevant experience performing pharmaceutical GMP quality assurance responsibilities. Additional previous development or production experience will be a great plus.

Essential Functions/Responsibilities:

• Working knowledge and understanding of current Good Manufacturing Practices with 21 CFR Part 210 & 211 and ICH Q7 Guidance.
• Proven ability to revise and update SOP's and policies to comply with regulatory requirements.
• Maintain document control and training programs.
• Capable of reviewing quality system related records e.g., deviations, change control, CAPAs, incidents and OOS investigations.
• Support both internal and external inspections/audits.
• Provide quality support to ensure regulatory compliance with the GMP production and analytical labs, vendor qualification, facilitating necessary equipment/instrument qualification and validation activities.
• Collaborate with other QA team members and cross-functional stakeholders to provide input to support GMP activities/projects.
• Perform quality review of material and product disposition documents, batch production related records, analytical/QC related testing records, protocols and reports.
• Participate in continuous improvement efforts and implement changes for improvement.
• Perform other activities as assigned by the QA head.

Job Type: Full-time

Job Types: Full-time, Part-time, Contract

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

Supplemental Pay:

• Bonus pay

COVID-19 considerations:
We have always followed CDC guidance for work place safety and hygiene. Sufficient supply of face masks and disinfection materials on site.

Experience:

• Pharmaceutical QA: 3 years (Preferred)

Work Location: One location