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
* Staff: Responsible for ensuring compliance with all local, national, 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 manufactures 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 years 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