Laboratory QA of QC Specialist

Job Description

Hercon Pharmaceuticals is dedicated to the manufacturing and development of generic transdermal medications. Managed by Zydus Cadila Healthcare, a fully integrated global healthcare provider, with strengths all along the pharmaceutical value chain, Zydus Cadila provides total healthcare solutions ranging from formulations, active pharmaceutical ingredients and animal healthcare products to wellness products. We are growing and have exciting opportunities available in our Pharmaceutical Transdermal Manufacturing Facility located one hour from Baltimore MD in York, PA.

The QA (quality assurance) of QC (quality control) Specialist, reporting to the head of Quality Assurance, has primary responsibility for ensuring the quality control and development laboratories are compliant with GMP regulations, USP Pharmacopeia, and ICH standards. Provides quality review of laboratory documents including raw data, specifications, SOPs, test methods, and validation documents. The incumbent will research and stay current with regulatory and industry standards, applying this knowledge to laboratory compliance and improvement.

Educational Qualifications:

• Bachelor of science in chemistry (or equivalent)

Required Experience:

• Minimum 5 years of relevant experience in pharmaceutical QC laboratory and quality assurance roles
• HPLC experience
• Desirable to have transdermal, topical, adhesive, liquid or ointment creams scale-up experience.

Essential Functions/Responsibilities:

• Establish program for quality assurance review of quality control operations
• Ensure laboratory compliance to all specifications, SOPs, ICH, and appropriate standards
• Laboratory data review in support batch disposition; cross check to raw data and calculation assurance
• QA review of analytical technology transfer and method validation
• Assure 21 CFR Part 11 compliance in laboratory operations
• QA review of stability protocols and stability data
• Review calibration records of laboratory instruments
• Collaboration with Corporate Quality, vendors, and contractors for compliant laboratory validation documentation
• Conduct of audits for internal and contract testing laboratories
• Review of OOS investigations and other laboratory incidents
• Evaluate change proposals presented by the laboratories
• Verify the training of analysts for assigned work
• Support quality inspection and audit of manufacturing areas
• Gathers and compiles information in responsibility area for quality reviews and regulatory submissions (e.g. Annual Report, MRB, ANDA etc.)

We offer a competitive salary and benefits package. Submit resume to hr@herconpharma.com

Current Openings for Laboratory QA of QC Specialist Jobs at Zydus Pharmaceuticals