Job Summary:

The QA Process Validation Specialist is a key contributor to the establishment of new pharmaceutical manufacturing processes and sustaining the operation of existing processes in a highly regulated environment. Validation Specialists use a combination of engineering principles, technical writing, and statistical methods to create high quality evidence of the safety and consistency of the active pharmaceutical ingredients manufactured by PolyPeptide. Working with a team of other highly skilled specialists, the QA Process Validation Specialist represents the quality organization in these teams.

Key Responsibilities:

1. Manage Process Validation Documentation: Draft, review, approve API Process Validation, Protocols and Reports to ensure that documentation is in alignment with established procedures.
2. Maintain the Periodic Review of the Validated Processes: Perform Annual Product Quality Reviews for Approved APIs as well as continuous statistical analysis of the processes.
3. Assist with the generating of FMEA Risk Assessment in support of the Critical Process Parameters to support he Process Validation Reports.
4. Collaboration with process development, manufacturing and quality groups using principles of concurrent engineering to ensure manufacturability of the process. Support in-house manufacturing group and/or PPL sites for scale-up and tech transfer of manufacturing processes.
5. Assist with Cleaning Validation Program and ensure adherence to Guidelines.
6. Review and approve documentation related to Equipment Validation and Environmental Monitoring,
7. Operate under cGMPs and perform additional Quality Assurance duties as necessary.

Qualifications:

Education & Experience

• Required Education: Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related field.
• Experience: Minimum 5 years in pharmaceutical manufacturing or a regulated environment; peptide manufacturing experience preferred.

Skills & Competencies

• Technical Skills: Knowledge of FDA, EU, and global GMP's including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11. Experience with Analytical Software (e.g. MiniTab).

• Soft Skills: Must have the ability to successfully manage multiple concurrent tasks, deadlines, and priorities. Must collaborate across organization and functional boundaries, including with customers, as a team player. Must demonstrate operational excellence.

Work Environment & Physical Demands:

• Physical Requirements: Ability to sit at desk for long periods of time. Capacity to lift or move light-to-moderate weight boxes.
• Work Environment: Main work setting is an office environment. Occasionally in a cGMP-compliant manufacturing and lab environment requiring Person Protective Equipment.

Performance Metrics (KPIs):

• Compliance Rate:
• Maintain [e.g., 98%] adherence to cGMP standards, evidenced by minimal deviation or findings during internal and external audits.
• Documentation Accuracy:
• Achieve 100% accurate in validation documentation with no major discrepancies identified during audits.
• Delivery Targets:
• Meet or exceed [95%] of on-time project delivery targets.

Salary: $85k-$88k per year

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.