What are the responsibilities and job description for the Quality Assurance Analyst position at Ampcus, Inc?
Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.
Job Title: Quality Assurance Analyst
Location: Fort Washington, PA
Job Summary:
Our client is looking for Quality Assurance Analyst. 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.
Job Responsibilities:
Job Title: Quality Assurance Analyst
Location: Fort Washington, PA
Job Summary:
Our client is looking for Quality Assurance Analyst. 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.
Job Responsibilities:
- Ensuring quality and compliance in all my actions by:
- Attending GMP training on the schedule designated for the role and as appropriate for the 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.
- Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and remain update to date 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.
- 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.
- Provide support to capturing of site metrics and promote improvement opportunities.
- Facilitate resolution of issues to improve site metrics.
- 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.
- Performs other related duties as required.
Ampcus 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, age, protected veterans or individuals with disabilities.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.