Associate II, Quality Assurance (Night Shift)

resilience; Olde West Chester (OH); Vor Ort; USD 60.000 - 90.000; Vollzeit

Benefits dieser Stelle

Annual cash bonus

401(k) plan with company match

Healthcare (medical, dental and vision

Paid vacation

Paid holidays

Tuition reimbursement

Zusammenfassung

Resilience is seeking a QA professional to support process execution within the Process Execution Team (PET) and in related areas, covering batch release, change control, validation, deviations, SOPs, and regulatory interactions.

Responsibilities include reviewing GMP documentation, batch records, product releases in SAP, investigations, validation plans, and SOPs; collaborating across QA to ensure compliant, efficient processes.

Qualifikationen

• Experience in pharmaceutical QA, operations, or QA environments.
• Excellent oral and written communication skills.
• Strong motivation to learn and develop in cGMPs.

Aufgaben

• Maintain understanding of production processes and quality systems.
• QA review and approval of GMP documentation affecting activities and facilities.
• Collaborate to ensure consistent application of key quality systems.
• Execute QA processes including batch record review and product disposition.
• Interface with site support groups on projects ensuring GMP compliance.
• Collaborate to drive process improvements and risk assessments.
• Stay abreast of evolving regulatory practices and recommend implementations.
• Contribute to data analysis and reporting of quality metrics.

Kenntnisse

Quality Assurance

GMP knowledge

Documentation review

Cross-functional collaboration

Regulatory knowledge

Ausbildung

Bachelor's degree in science

Master's degree desirable

Tools

SAP

Jobbeschreibung

Position Summary & Responsibilities

This position is responsible for all QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PETs. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

Responsibilities

• Maintain a high level of understanding of relevant production processes and quality systems
• Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable:
  • Change Requests
  • Batch Records and associated documentation
  • Product and Component Release transactions in SAP
  • Quality Investigations (Deviations, Product Complaints)
  • Validation Plans, Protocols and Reports
  • Standard Operating Procedures
• Collaborate with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
• Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives
• Interface with applicable site support groups on projects (capital and non-capital) that impact the PET/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects
• Collaborate with and influence other PET/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices
• Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders
• Collaborate in data analysis and report creation on quality metrics and key performance indicators

At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs.

Hours (Night Shift): 6 PM-6:30 AM 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts over

Minimum Qualifications

• Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance
• Excellent oral and written communication skills
• Strong ability and motivation to learn

Preferred Qualifications

• Bachelor's degree; master's degree in science is desirable
• Previous experience in a Lean, process-centric organization with an emphasis on continuous improvement
• Multi-site / multi-functional experience

Sponsorship or support for work authorization, including visas, is not available for this position.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $60,000.00 - $90,000.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills and knowledge.