Position: Quality Assurance Specialist

Type: on site in King of Prussia

Company: SK Pharmteco

The Quality Assurance Specialist supports the organization by establishing/enforcing quality systems, drive growth, and ensure quality among the site. The QA Manufacturing Operations Specialist supports Manufacturing Operations, providing oversight, strategic thinking, and results focus to reliably meet and/or exceed the site’s production targets while achieving high levels of quality. This position requires an individual capable of partnering across the organization to manage a fast-paced production environment and deliver exceptional service to our clients. It also ensures business, quality and compliance goals are met in full compliance with all government-issued environmental, health, safety, quality, and regulatory policies and guidelines.

Responsibilities:

• Support on the floor activities through shop floor QA procedures.

• Assist in management and triage of on the floor events and schedule of on the floor support across specialists.

• Provide Quality input and guidance for deviations, technical documentation, program/process

optimization projects, and audit readiness initiatives.

• Review minor deviations and recommend CAPAs and effective checks to ensure robust

investigations and actions.

• Review Change controls and continuous improvement records.

• Communicate effectively with cross functional departments to ensure on time delivery of QA

review and disposition responsibilities

• Compile batch documentation and generate Certificate of Conformance for release of

manufacturing batches within assigned timelines to effectively deliver results to client.

• Ability to review data and effectively identify trends or key issues.

• Ensure facility follows current GMP standards (cGMP)

• Support the development of quality systems including a robust and on-going quality improvement system compliant with GMP.

• Review pre executed and executed master batch records and facilitate comment resolution with

applicable manufacturing teams.

• Review process flow diagrams to support tech transfer program initiatives

• Sit in on internal client calls and support external calls as applicable to ensure timeline deliverables

and compliance to procedures.

• Work with QA and management to collaborate with clients to generate labels for client programs.

• Complete line clearance and changeover activities to support product campaigns.

• Print master batch records to support client programs and internal manufactured products and

aseptic manipulation qualifications.

• Oversee Aseptic process qualifications (APS) and vial inspections for APS and Drug product.

• Review environmental monitoring(EM) data to support changeover of suites as well as in process EM.

• Review material specs to support client programs.

• Review and approve new procedures.

• Facilitate review of document change controls for SOP revisions.

• Additional duties as assigned.

Requirements:

•Minimum 5-7 years’ experience in the pharmaceutical or biopharmaceutical industry

•Minimum 3 years’ experience in a quality role in pharmaceutical or biopharmaceutical industry

• Proficient in Verbal and Written communication skills

• Excellent problem solving, risk analysis and negotiation skills

• Ability to review data and effectively identify and trends or key issues

• Ability to manage multiple projects simultaneously ensuring on time execution of deliverables

• Flexibility to support operations as needed

N/A As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status