- QA presence on the Production Floor, Warehouse and Final Pack
- Ensure compliance to the relevant SOP and corporate standards, regulatory standards, and procedures.
- Performs work that requires decision making and the consistent exercise of independent judgment and discretion.
- Ensure that documentation and operations meet established requirements of cGMPs, Internal SOPs and company policies. Draft and revise procedures as required.
- Participate in investigation of non-lot associated quality events and change controls
- Participate in assigned site QA projects
- Perform Quality Assurance review for deviations, investigations, SOPs and quality-controlled documents.
- Promote a quality mindset and quality excellence approach to all activities.
- Ensure proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all manners.
- Support GMP compliance and inspection readiness activities.
- Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.
- Ability to learn, follow and exemplify "Good Lab Practices" and GMP requirements
- Perform testing of batches to ensure the final product specifications are met.
- Perform mathematical calculations that ensure results are in alignment
- Document and enter batch data into all relevant software utilizing proper documentation requirements (GDP)
- Performs incoming inspection and re-testing of product components, labels and raw materials, occasionally lifting cartons or spools of wire weighing up to 50 pounds.
- Conducts basic statistical evaluation of incoming and in-process inspections.
- Participates in Marketing Fulfillment operations, including picking and packing of orders
- As business needs dictate, works extended hours to complete daily department goals or tasks to include mandatory overtime
- Minimum high school education, 2-year technical degree preferred
- Quality Assurance experience and knowledge of basic process controls preferred.
- Quality Control Knowledge and able to execute standard quality control methods in a laboratory/Controlled environment
- Strong Computer Skills
- nowledge of cGMP regulatory requirements and related laws.
- Intermediate skill in the use of Excel, Word and PowerPoint.
- Ability to read, write and understand highly technical material.
- Knowledge of standard laboratory equipment and methods (analytical scale, Bubble Testing, etc.)
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Quality Technician 1 - North Tonawanda, United States - Cooper Companies
Description
Job DescriptionAbout CooperSurgical
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at
Responsibilities
The QA Technician will participate in tasks cross-functionally in Plant Production Quality Assurance and Plant Quality Control. This position will assist in maintaining GMP compliance for Plant Production and perform routine laboratory testing for raw materials, in-process material, and final release product.
Quality Assurance:
Education:
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.
