Fulltime, Permanent
SUMMARY OF POSITION:
The Independent Quality Auditor (IQA) is a resource and a go to person for quality support and laboratory personal. Primary responsibilities include quality over laboratory data review for QC chemistry and Microbiology, potential educator of laboratory personnel of compliance, procedure and particle performance. He/she makes sound decisions to meet FDA, EU, MHRA and product requirements. Make judgments on observations during review and provide resolution. Have a good degree of initiative to resolve problems, discuss and research action to be taken before finalizing a resolution.
- Support the Quality Assurance Group to provide effective, timely, and efficient oversight of the compliance of internal laboratories with the requirements of the US and EU standards.
- Strong knowledge in quality, analytical chemistry, and microbiology, along with function of a quality control laboratory environment supporting a pharmaceutical TS facility.
- Knowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.
- Must have good organizational, presentation, meeting facilitation and technical writing skills.
- Strong knowledge and practical use of laboratory equipment; HPLC, GC, titrator, AA, UV /VIS, pipette, and pH meters, Micro and Rodac plates, bio burden and endotoxin testing. etc.
- Basic to intermediate proficiency in Microsoft Office and statistical programs (i.e. MiniTab, Total Chrom, Empower, LIMS).
- Need to be familiar with a Quality Control laboratory environment, procedures, analysis and understanding of laboratory calculations, conversions and units.
- Verify accurate transcription of raw data into reports and laboratory documents. Audit testing for compliance to all applicable SOPs, methods and regulatory requirements.
- Discuss issues with lab staff as discovered during review of data packet, OOS, exception and CAPAs,
- Auditing back ground, and ability to work/contribute in a team based environment as a lead and a participant, exceptional interpersonal skills, and adept problem solving skills.
- Need to familiar with non-conformity and resolution process.
- Adherence to SOP’s, policies and procedure associated with laboratory functions.
- Ability to utilize Microsoft office, Word, Excel, Project, TotalChrom and LIMS system or equivalent.
- Working knowledge of green belt- lean tools and focus factor
- Able to respond/react with appropriate urgency/ professionalism and make decision under pressure.
- Support goals and initiative tied to Quality Plan and department goals
- To develop and present presentation and training to individuals and groups
- Evaluate current systems and process to determine upgrades, additional technology and improve as needed.
- Write, and review required document to execute the duties of the position
- Knowledge of pharmaceutical documents to be reviewed during an audit: validation lifecycle; URS, DQ,
- Protocol { IQ, OQ, PQ, PPQ}, batch records, change request, Risk Assessments, Reports, laboratory data,
- Test plans/ Transfers, laboratory documents/ Testing, Investigation, CAPAs, complaints and SOP’s
- Write, revise and / or review SOP’s for approval.
- Assist in the department completion of trending and metrics
- Ability to track the performance of assignments through to completion.
- Represent quality as an adviser when on assigned to a project.
- Readily identify and analyze problems and generate effective courses of action.
REQUIREMENTS:
BS/BA degree in chemistry, Microbiology, or Life Sciences
Minimum 4-5 years’ experience in a pharmaceutical, a least 2 years’ laboratory and 2 years quality
ASQ certified inspector/auditor preferred
Experienced in conducting pharmaceutical cGMP audits
Knowledge of cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures.
Good documentation skills with eye for details
Strong computer, scientific, and organizational skills
Excellent communication (oral and written) and attention to detail
Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Strong command presence, professional decorum with customer (internal and external), initiative, and good collaborative skills
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
The position routinely interfaces with various personnel from all site departments (Chemistry, Microbiology, Release,
M&D), as well as, corporate personnel and external suppliers. The position will require independent decisions and
personal judgment based on Company policies, SOPs, and GMPs.
WORKING CONDITIONS:
First shift office environment. Overtime or weekend work is dependent upon site demands. Minimal travel to assist in vendor audits, as needed. Visits to laboratory, manufacturing, warehouse and other plant areas are required. Minimal travel related to Supplier Management program.