The Opportunity:
Responsible for providing supervision of inspection process and staff. Ensure staffing levels and work assignments meet facility requirements. Assist in the administration of the Quality Assurance (QA) and Quality Control (QC) programs and ensure compliance with the Quality Manual as well as all applicable regulations and standards for which Therapak/VWR is certified to. Perform acceptance activities as required to ensure Company objectives are met. May provide oversight to lower-level supervisor(s).
What we are looking for:
- Bachelor’s degree in chemistry, Biology, Biochemistry or science related field
- 5 years of related/applicable lab experience; minimum 1 year of supervisory experience
- Required language(s): English
- Required Skill(s): MS Office (Words, Excel and Access)
- Ability to work in a team environment
- Ability to identify and resolve issues
- Ability to lead a team and provide guidance
- Strong decision-making and communication skills
- Strong interpersonal and organizational skills
How You Will Thrive and Create an Impact:
Supervision of QC Associates
- Directly supervises the quality control associates, monitor individual skills, technique and abilities for most efficient operation.
- To follow progress of work; anticipate or investigate delays or inadequate performance by taking corrective action within limits of established practice and aid other departments as needed.
- Provides on the floor and technical support to quality control associates with guidance and improve the quality system, regulatory policies and procedures.
Drive QC Operation and Laboratory Operational Excellence
- Support and enforce the quality management system related to QC, regulatory policies and work instructions.
- SAP account holder for method creation, support QC data input and release, inspection plans and reports creation to ensure the process flow is smooth.
- Oversee quality and quantity of all QC laboratory output and testing timelines by monitoring testing duration, arrange for equipment, materials and supplies to be available for QC testing
- Oversee that equipment is given proper care; troubleshoot faulty operations to determine cause and arrange for required repair and maintenance which could affect operational testing needs
Drive continuous QC training and development
- Provide or arranges for training and cross training to employees in the performance of duties by assisting and instruct personnel as necessary to insure proper flow of work through department.
- Provide guidance to all level Technicians including test methods, analytical technique, good laboratory practice, paperwork completion, equipment, schedule interpretation, and LIMS support.
Maintain QC Document Control and lead in investigation
- Review and approval of controlled Quality Control documents including but not limited to specifications, procedures, work instructions, validation protocols, equipment software audit trials, stability worksheets, data integrity logs and validation reports.
- Ensure department documents and procedures are up to date and reflect current practice; revising procedures & processes when needed.
- Performs investigations for laboratory out of specification (OOS), out of trend (OOT) questionable results, quality event, CAPA and complaint related to testing, safety related incidents and/or processes related to the QC laboratory.
Maintain Quality, Regulatory and Safety Compliance
- Understands regulatory requirements for 21 CFR 820, ISO 17025, EXCiPACT, GLP, GMP including USP/EP/BP/JP/ChP general practices and procedures.
- Proactively maintains current industry and regulatory knowledge for medical devices, ISO 17025, GMP principles and current analytical methodology.
- Enforce prescribed local safety rules and regulations related to QC laboratory; insure that work areas are maintained in a neat and orderly condition in the work environment; to perform safety and security procedures to open and close buildings and facilities.
Customer Centric
- Work with external customers, regulatory agents and vendors during audits and site visits.
- Work and collaborate with internal stakeholders to insure successful visits and audits
QC Decision Making for Operation
- Assist in determining priority of urgent items and appropriate action plan to effectuate priority.
- Drive all QC decision making in approve rejections and rework actions as recommended by Quality Control Technicians.
Additional Assignments
- Performs other duties and ad-hoc projects as assigned to drive growth, operational excellence and organization goals.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.
Why Avantor?
Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!
EEO Statement:
We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.
If you need a reasonable accommodation for any part of the employment process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
3rd party non-solicitation policy:
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation
