Overview
Quality Engineer Jobs in York, PA at Apex Tool Group
Our Manager of Quality Assurance plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include managing all Quality Assurance aspects of compounding sterile pharmaceuticals for compliance within the facility. Operates within the legal and regulatory compliance, producing a quality product. Operates the area as the manager over the QA operations/staff, coordinating day to day functions. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.
What Manager, Quality Assurance Does Each Day:
Manages all Manufacturing QA staff providing learning and development where appropriate
Ability to make QA decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
Responsible for timely and accurate in process review of batch records and QA checks within the manufacturing process
Provides review/approval of Deviations / Investigations, CAPAs, Change Controls
Generates procedures related to Manufacturing QA functions / activities
Designs and maintains the environmental monitoring program including environmental and personnel monitoring results that exceed alert or action limits and interpreting results
Trains personnel on appropriate aseptic techniques and gowning techniques
Periodically review records to verify that quality standards for each drug product is met
Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
Responsible for maintaining QA records associated with internal and external testing
Responsible to maintain all testing equipment in compliance, calibration, and certification
Assists in developing policies and procedures related to QA
Promptly communicates with Operations regarding complaints, product issues/variances
Enforces applicable personnel policies and procedures
Our Most Successful Quality Assurance Managers:
Have strong technical writing and verbal/written communication skills
Develop action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics
Possess time management skills
Minimum Requirements for this Role:
Bachelor’s Degree in Life Science or other related field required
5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry
3 years of supervisory or management experience required
Experience training personnel on aseptic techniques and appropriate gowning techniques
Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
Must be currently authorized to work in the United States on a full-time basis; QuVa is not able to sponsor applicants for work visas
Any of the Following Will Give You an Edge:
Understanding of process flows, gap assessments and analysis of data to drive improvement
Proficiency with computerized tracking tools
Comprehensive knowledge of adult learning techniques
Benefits of Working at QuVa:
Comprehensive health and wellness benefits including medical, dental and vision
401k retirement program with company match
22 paid days off plus 8 paid holidays per year
National, industry-leading high growth company with future career advancement opportunities
About QuVa:
QuVa is a national, industry-leading provider of pharmacy services, including ready-to-administer sterile outsourcing and advanced AI-generated insights providing clarity for revenue capture and inventory management. QuVa Pharma delivers essential medications in injectable formats critical for effective patient care. LogicStream, a QuVa company, partners with health systems to aggregate, normalize, and analyze large amounts of complex data through AI and machine learning tools that generate actionable insights supporting revenue optimization, inventory management, and inventory-related workflows. Through QuVa’s integrated solutions, health systems can transform pharmacy management to achieve greater value by operating more efficiently and effectively as they deliver high-quality patient care.
QuVa is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. QuVa’s Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with QuVa is “at will.”
Title: Quality Engineer
Company: Apex Tool Group
Location: York, PA
