Quality Specialist Pharmaceuticals

Overview --------

WuXi STA Breaks Ground for New Pharmaceutical Manufacturing Facility in Middletown, Delaware | WuXi STA About WuXi AppTec | Global CRDMO Leader Enabling Healthcare Innovation Worldwide

Job Summary ------------

The Quality Specialist will work closely with operations and manufacturing personnel to ensure compliance with SOPs. The ideal candidate is a detail-oriented professional with a strong background in pharmaceutical quality assurance, capable of thriving in a fast-paced, startup-like environment while adhering to GMP (Good Manufacturing Practices) and other regulatory requirements.

Responsibilities ----------------

• Provide on-the-floor operational and manufacturing support.
• Participate in the implementation of the QMS at the new manufacturing site, including developing and documenting processes for solid oral dosage, API, and aseptic small molecule production to ensure compliance with FDA, EMA, and other regulatory bodies.
• Review and approve facility, utility and equipment CQV documentation such as URS, FAT, SAT, turnover packages, installation/operation/performance qualifications, and process validations.
• Conduct readiness inspections of manufacturing areas, equipment, computerized systems, and processes to identify and mitigate potential quality risks prior to operational startup.
• Create and support employee training programs on quality systems, GMP, and related topics to foster a culture of quality and compliance.
• Assist in the review of batch records for accuracy and completeness, contributing to product disposition decisions as needed.
• Support deviation investigations and review and approve QMS documents such as change control, deviations, CAPA, continuous improvements, and effectiveness checks.
• Collaborate with cross-functional teams (e.g., manufacturing, engineering, and regulatory affairs) to integrate quality principles into daily operations.
• Maintain accurate records and documentation in compliance with data integrity standards.

Qualifications --------------

• Bachelors degree in Pharmacy, Chemistry, Biology, Engineering, or a related scientific field.
• Minimum of 2 years of experience in pharmaceutical quality assurance, preferably in various dosage forms such as solid oral dose and small molecule sterile injectables.
• Proven experience in QMS implementation, internal auditing, and managing regulatory audits.
• Strong knowledge of GMP, ICH guidelines, ISO, and ISPE guidelines.
• Certifications in auditing and quality management from ASQ or other professional organizations.
• Excellent analytical, problem-solving, and communication skills, with the ability to influence stakeholders at all levels.
• Proficiency in quality management software and Microsoft Office Suite.
• Ability to work independently and as part of a team in a regulated, high-pressure environment.
• Willingness to travel occasionally for audits or training.

Preferred Skills ----------------

• Experience in a greenfield manufacturing site startup.
• Experience in OPEX and Lean Six Sigma concepts.
• Experience in OSD manufacturing processes.
• Familiarity with aseptic processing and sterile product manufacturing.
• Training certification (e.g., in GMP or quality systems).
• Knowledge of risk management tools (e.g., FMEA).
• Knowledge of quality engineering and statistical process control concepts.

Company Overview ----------------

WuXi STA is a leading global Contract Research, Development, Manufacturing, and Outsourcing (CRDMO) organization enabling healthcare innovation worldwide. With a strong focus on quality and compliance, WuXi STA is committed to delivering innovative solutions to its clients.

Equal Opportunity Employer -------------------------

WuXi STA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.