Job Description

Summary

The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities.

Responsibilities

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies' policies, procedures and guidelines, this position:
• Ensure quality and compliance in all my actions by: All employees:
• Attend GMP training on the schedule designated for my role and as appropriate for my role.
• Adhere to strict compliance with procedures applicable to my role.
• Exercise the highest level of integrity in the tasks that I perform.
• In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
• Embrace a behavior of employee involvement and commitment to doing the job right the first time. People Managers
• Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
• Promote an environment of employee involvement in the workplace.
• Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

1. Quality Assurance and Compliance Focus

• Provides daily 'Shop Floor” QA support to warehouse, bulk manufacturing and packaging lines.
• Provides leadership support to QA Shop Floor activities including communication of quality events to management.
• Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
• Provides support to Investigations and/or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.
• Performs or supports activities related Line Audits, Line or Area Cleaning Verifications
• Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's).
• Provides support to Consumer Complaint investigations.
• Provide QA support to various project teams, as needed.
• Actively supports Site metrics, compliance improvement and training initiatives.

2. Customer and Performance Improvement Focus

• Provide support to capturing of site metrics and promote improvement opportunities. Facilitate resolution of issues to improve site metrics.

3. People & Organization Focus

• Provides training and direction as needed to new employees
• Teams with Department members for process feedback and continuous improvement opportunities
• Represents Quality Assurance in positive manner

4. Performs other related duties as required.

What we are looking for Qualifications:

• 3-5 years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement
• Technical B.S. or B.A. College Degree in Science is preferred.
• Active cGMP Interpretation and Application Experience
• Demonstrated leadership- possesses the ability to lead a team
• Strong Organizational Skills
• Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
• Problem Solving/Investigation Experience
• Expertise in Handling Multiple Priorities
• Process and Systems Experience, especially with SOPs, MBRs, Change Controls, Non-Conformance
• Investigation Documentation
• Experience with Liquid Dose processing and packaging technology preferred.
• Validation Experience preferred

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