Job Description
SECTION 1: JOB SUMMARY*
- Carry out QC testing to ensure the ongoing quality of product
- Interface with other departments to ensure timely release of products and materials
- Support with laboratory investigations and non-conformance investigations
- Ensure the principles of cGMP are applied and that all documentation is followed to comply with ISO9000, ISO13485, FDA QSRs and the Medical device directive
- Support documentation revisions
SECTION 2: DUTIES & RESPONSIBILITIES*
Under supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position involves:
- Ensure that QC testing is performed in a timely manner
- Day to day performance
- Physical testing of raw material, in process and finished product
- Analytical testing of raw material, in process and finished goods
- Chemical testing of raw material, in process and finished goods
- Management of consumables and materials used in testing
- Cleaning of items for testing within the laboratory
- Execution of the laboratory cleaning program
- Review of internal and external testing data
Quality and Compliance Related Responsibilities
- Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations
- Responsible for ensuring compliance with all local, international and company regulations, policies and procedures for Health, Safety and Environmental compliance.
GMP documentation and Quality Systems
- Support investigations to assist in the completion of Non-conformance reports and OOS excursions
- Training: Ensure that own training records are up to date and complete
- Assist in the training of other staff
Validation
- Support validation of test methods and equipment for the QC department
External communications
- Liaise with approved manufacturers to ensure data is retrieved and available
- Ensure that consumables are ordered in a timely manner to avoid testing delays
SECTION 3: EXPERIENCE AND EDUCATION*
- Minimum of A level in science or mathematics discipline (international equivalents acceptable)
- Desired BSc degree in Scientific subject (Chemistry, Pharmacy, Forensics etc…)
- Minimum 1 year experience in a laboratory setting (Practical laboratory experience gained through a degree is acceptable)
- Working with Microsoft Office applications (Word, Excel, PowerPoint, Office)
- Desired previous experience working within a quality environment in the Food, Consumer, Pharmaceutical or Medical device industry
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
- Able to follow procedures to ensure the principles of cGMP are upheld
- Able to communicate and present information and ideas effectively
- Able to work to deadlines
- Able to react to a changing environment and under time pressures
- Able to work as part of a team to work towards a common goal
- Able to manage own time and prioritize own workload to ensure timely completion of assigned work
- Credo values: Integrity and Credo based actions
- Customer focus: Results and performance driven with a sense of Urgency
- Talent development: Collaboration, Self-awareness, Adaptability