QC Senior Specialist in Sugar Land, TX at APEX Systems

Date Posted: 12/4/2019

Job Snapshot

Job Description

Job #:  1020353
POSITION PURPOSE
A brief summary of the purpose this position must fulfill.
 
Administrator/Administration support for Empower Network and Laboratory Systems: Stand Alone Systems, Computer System Validation (CVS) to laboratory instruments controlled by a computerized system.  Coordinate Change Controls and protocols for QC Systems.
Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.  
 
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this position successfully, an individual must satisfactorily perform each essential duty.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
1. Administration of Laboratory Stand-alone Systems and Empower: Hardware/Software Set up and Configuration, User Access Management, System Policies Management and Periodic Reviews.
 
2. Create Validation documents, conduct risk assessments on Laboratory systems, develop corrective and preventive action plans, Change controls (interim controls) and implementing remediation activities to ensure systems remain 21 CFR part 11 compliant.
 
3. Maintain compliance of Laboratory Systems with all established IT and software policies and procedures.
 
4. Support Computerized System Validation Activities for Laboratory Systems with Validation Team:  Participating and Authoring, Review and Execution of test scripts/protocols for Functional Design verification and validation of Laboratory Systems configurations.
 
5. Provide end-users Training.
 
6. Initiate and manage relevant change controls, Investigations and CAPA required at all stages and operational life of each system.
 
7. Perform review of System Audit trails / Event logs / Message Center records and communicate findings that may impact data integrity.
 
8. Perform other duties as assigned.
 
QUALIFICATIONS
The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.
 
KNOWLEDGE 
Must possess knowledge of Quality functions, Title 21 of the Code of Federal Regulations (CFR 21), Computer Compliance regulations, Windows Operating System, knowledge of networks, FDA regulations for the pharmaceutical industry.  Must be able to understand and adhere to Company and departmental policies and procedures as well as government regulations.  Must possess knowledge of relevant SOPs and cGMPs.
 
 
SKILLS AND ABILITIES
Must possess good written and oral communication skills as well as interpersonal skills.  Must also possess computer skills and ability to use Microsoft Office including Word and Excel and Windows based software.  Familiar with Manufacturing, Regulatory Affairs, Quality Assurance and Quality Control environments is a plus. Ability to work and interact with other employees at all levels.
 
SUPERVISION
Position reports to Director, Quality Control.
 
EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) of Science/Arts in a science related field and 2-4 years of experience in the Pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration. 
 
LICENSES/CERTIFICATIONS
None required
 
LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents.  Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.
 
REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
 

 
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.