Sr Compliance Specialist R&D

Job Summary

The Sr Compliance Specialist is responsible for QA review of Research and Development reports, documents, and systems to ensure compliance with internal Standard Operating Procedures, Company policies (as applicable), and cGMP requirements. Assists QA management in efforts to improve compliance at the R&D laboratory.Responsibilities

• Reviews R&D stability summaries against Stability Testing Protocols (STP) and Finished product specifications to ensure results are within acceptance criteria and tested within assigned stability windows
• Reviews and approves method validation and formulation label support reports to ensure all results are within acceptance criteria and any deviation from the protocol is addressed appropriately
• Reviews and approves cGMP protocols, among them analytical method validation protocols, formulation label support studies, and STPs. Ensures the protocols comply with ICH and internal requirements
• Reviews cGMP-controlled documents such as SOPs, Specifications, and Methods of Analysis (MOA)
• Identifies and promotes improvements in laboratory systems to enhance compliance and lead initiatives to implement changes in these systems
• As directed, performs spot audits of raw data in Lab notebooks, eLab Notebooks, Chromatograms, and other laboratory data
• Reviews and approves Out of Specification(OOS), Out of Trend(OOT), and Deviation Investigations
• Assists in maintaining tracking spreadsheet for documents in QA review
• Represents Quality in Project teams to ensure quality requirements are met during development, and support the identification and assessments of risks expected in new product development
• Performs QA usage decision for release of product development materials in SAP.
• Performs internal audits of R&D systems, assists in drafting audit report, communicates findings to site senior management, and assists in the review of Corrective and Preventive Actions (CAPAs)
• Assists in retrieving and copying documents for regulatory inspections
• Assists during regulatory inspections
• Maintains knowledge of cGMPs and keep current with training needs
• Review Critical Process Parameters (CPP) and Master Batch Record Requirements (MBRR’s) for new Exhibit Batches
• Review and approve outside lab test protocols and reports
• May be called on to assist with tracking of the publication of new Global Documents and keeping the site tracking list up to date
• May be asked to oversee time tracking of the QA team
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirement

· Bachelor’s degree, preferably in the basic sciences (i.e. Chemistry, Biology)

· Minimum 5 years of experience.  Research and Development setting with a pharmaceutical company is preferred

· Experience with performing risk assessments a plus

· Working knowledge of cGMP, CFR, ICH, and ISO 9001 standards

· Attention to detail is required

· Ability to comprehend laboratory procedures and assess compliance against set procedures

· Requires good interpersonal, organization, and communications skills

Team leadership experience a plus.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.