QC Systems Administrator

Position Summary:

The QC (IT) Systems Administrator will support all administrative functions associated with lab systems and equipment in a pharmaceutical environment. The QC Systems Administrator will assist in the implementation and maintenance of all computerized GxP Instruments, benchtop lab equipment, computers, standalone instruments (networked and non-networked), firmware-based instruments, HMI’s and any GxP application software as needed by the company. Candidate must be able to perform basic IT functions, routine maintenance, repairs and user management according to standard operating procedures.

Responsibilities

• Ensure that Backup and/or Recovery of all GxP systems is being performed as required per indicated routine schedule assigned by IT Management through application of cGMP principles and following internal standard operating procedures (SOPs), work instructions (WIs), and regulatory requirements.
• Protecting classified data from being altered, modified, and or deleted
• Manage User Access including user creation and activation and/or deactivation of users on GxP systems.
• Assist in the implementation, maintenance, and support of GxP applications and systems in a controlled laboratory and manufacturing environment as well as retirement of GxP systems.
• Conduct Periodic Reviews of User Access Management, Systems Validation Reviews, SOP Reviews etc. to confirm computerized systems are compliant with company procedures and regulatory agency requirements.
• Propose alternate processes, procedures, and process automation pathways to streamline and increase effectiveness and efficiency of IT operations.
• Collaborate with various stakeholders globally and/or across sites within the region to understand and implement best practices.
• Support regulatory, customer and other such audits from IT department.
• Supports the implementation of 21CFR Part 11 laboratory software.
• Partners with Computer System Validation (CSV), IT, QC, and QA to ensure data integrity best practices are aligned and followed.
• Pulls system audit trails at prescribed intervals and escalates any data integrity concerns.
• Supports process execution with quality systems.
• Helps to compile data for documentation of test procedures.

Education and Experience

• Bachelor's Degree with a background in Life Sciences, Pharmacy, Computer Science, Computer Information Systems (CIS) or related field preferred
• Strong IT experience, proficient in SQL, Active Directory, LDAP
• Experience within a cGMP / FDA / Biotechnological / Pharmaceutical environment is needed
• Prior experience with System Administration of standalone benchtop systems a plus

Functional Requirements

• Knowledge and understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System.
• Working knowledge of Microsoft Office Applications
• Strong understanding of good manufacturing practices and/or good laboratory practices
• Working Knowledge of 21 CFR Part 11 compliance in a GMP/GLP regulated industry, Data Integrity, GDP and adherence to ALCOA principles

ANSA Compliance Non-Negotiables

• Need to be self-motivated and capable of working in a fast-paced environment
• Candidate must be dependable, reliable, and professional
• Must be able to demonstrate leadership in a dynamic organization
• Must demonstrate honesty and integrity
• Comply with the company code of conduct and policies and regulatory standards

Company

ANSA Compliance is a compliance service, project management, and staffing provider that specializes in serving the pharmaceutical, biotechnology, and medical device industries. With over 20 years of combined experience in the compliance sector, the ANSA team can support clients throughout any stage in the development lifecycle.

ANSA Compliance pledges to create and maintain a workplace where all employees have the chance to participate and contribute to the success of the business. Employees at ANSA Compliance are valued and appreciated for the skills, experience, and unique perspective that they bring.

Job Types: Full-time, Contract

Pay: $40.00 - $60.00 per hour

Compensation package:

• 1099 contract
• Hourly pay

Experience level:

• 2 years

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Sanford, NC: Reliably commute or planning to relocate before starting work (Required)

Experience:

• QC System Administration: 2 years (Preferred)
• IT: 2 years (Preferred)
• IT in Pharmaceutical Environment: 2 years (Preferred)

Work Location: One location

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