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Lead Data Integrity Associate- Gmp

2 months ago

San Diego, United States Ajinomoto Bio-Pharma Services Full time

**Why join Ajinomoto Bio-Pharma?**
- Our mission is to help improve the health of humankind._

We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.

We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees**.**

**Total Rewards package designed to make your life better**:
We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more

**Your next career move**:
We are currently seeking a **Sr Data Integrity Specialist II** who is part of the QA/Compliance team and is a Subject Matter Expert in data management across product lifecycles (i.e., supporting product development through CGMP clinical and commercial production). This individual is responsible for assisting in determining systems that are impacted by data integrity requirements, QA representative on workflow validations, and DI related risk management. The position requires a thorough understanding of existing and emerging industry data integrity and 21 CFR Part 11 requirements. The position requires strong technical knowledge of records management, GDPs, computerized production / laboratory and enterprise systems, CGMP processes, and risk assessments. This role works across hybrid systems (paper and electronic).

**Responsibilities**:

- Possesses expert level understanding of regulations, standards and guidelines and they pertain to DI. Ensures broad understanding across the organization and applies knowledge to changing business practices.
- May require client facing interactions related to DI and resolving client issues or addressing questions.
- Leading cross-functional activities, in providing approach, methodology and deliverables.
- Lead DI related change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state.
- Participates in regulatory inspections and preparation of site inspections.
- Perform workflow validations for DI related processes and identify hazards and risk mitigation strategies. Escalates compliance gaps to upper management as needed.
- Representing QA/Compliance in DI related emerging industry trends and topics.
- Develops proposals and strategies related to business strategy and future state operations.
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

**Requirements**:

- Master’s degree and 6+ years of experience in CGMP regulated environment with relevant experience or Bachelor’s degree and 8+ years of experience in CGMP regulated environment with relevant experience.
- Relevant experience is minimum of six to eight (6-8) years in QA, Compliance, Records Management, Data Integrity, and / or Computer System Validation (CSV).
- Experience must include proven knowledge of DI related risk assessments and identification of mitigation actions.
- Familiarity working with electronic batch records and LIMS preferred.
- Detail oriented and strong interpersonal and verbal communication skills.

New hires will be asked to complete a background check and drug screen as a condition of employment

We are an EOE dedicated to a diverse work force and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Pay: $95,000.00 - $134,000.00 per year

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance

Experience level:

- 6 years

Schedule:

- 8 hour shift

Application Question(s):

- How many years of GXP experience do you have?
- What are your general salary expectations?
- Do you have a Master’s degree and 6+ years of experience in CGMP regulated environment?
- Do you have a Bachelor’s degree and 8+ years of experience in CGMP regulated environment?
- Do you have a minimum of six to eight (6-8) years in QA, Compliance, Records Management, Data Integrity, and / or Computer System Validation?

**Experience