What are the responsibilities and job description for the PLS QA Specialist III position at Pace®?
This is a full-time Quality Assurance Specialist II position located in Oakdale, MN, from Monday - Friday, from 8:00 a.m. to 4:00 p.m.
Summary:
We are actively seeking a candidate to join our Quality Assurance (QA) Data Review team as a Quality Assurance Specialist III. The ideal candidate is one who thrives working in a highly dynamic, team-oriented environment sharing the common goal of providing our clients with the information they need to improve the safety and effectiveness of materials produced and used in pharmaceutical and medical device products.
The Quality Assurance Specialist III is responsible for the review of laboratory technical records. Laboratory testing can be documented on paper worksheets or in an electronic laboratory notebook. Laboratory testing varies from raw materials testing (e.g. USP, BP, EP), in-process, finished product release and stability studies. The tests vary in complexity from simple wet chemistry tests (e.g., visual titrations, residue on ignition) to biopharmaceutical techniques (e.g., ELISA, capillary electrophoresis) to more complex instrumental techniques (e.g., HPLC, HPLC-MS, GC, GC-MS, ICP-MS, MS-ToF). The Quality Assurance Specialist III reports to a QA Group Leader or QA Manager.
The ideal candidate is one who has a strong attention to detail and organization skills and is comfortable working independently. The ideal candidate is also self-motivated, demonstrating a strong work ethic and flexibility to adapt to a dynamic work environment and changes in work priorities. The ideal candidate thrives in a collaborative environment and is comfortable working with various departments toward a common goal of delivering client data and analysis reports by the due date. PLS encourages cross-training to develop new knowledge and skill sets. The ideal candidate is one who thrives in an environment of continual learning and growth.
Preferred qualifications include previous GMP laboratory or QA data review experience in various analytical techniques, such as UV-VIS spectrophotometry, HPLC, GC, HPLC-MSICP-MS, ELISA, and capillary electrophoresis. Experience with data acquisition software such as Empower and MassHunter is preferable. Previous experience with biopharmaceutical techniques, method development and validation, and stability studies would be ideal.
Job Responsibilities:
. Perform data review of laboratory technical records for quality system compliance while ensuring that client due dates are met
. Provide support to other members of the QA Data Review Team
. Review and approve final analysis reports
. Develop and maintain computer skills related to work performed, including familiarity with laboratory computer applications (e.g., ELN, LIMS, Empower).
. Assure all work performed is compliant with PLS SOPs and the quality management system
. Become familiar and regularly updated with quality and regulatory policies associated with the technical area.
. Participate in ongoing quality, cGMP, safety, method and technique training
. Other tasks as assigned by QA Management
Requirements:
. Keen attention to detail and adherence to SOPs and Good Documentation Practices within a cGMP environment
. Strong interpersonal skills
. Strong verbal and written communication skills
. Ability to excel in a fast-paced work environment
. Ability to work independently, multi-task, and be flexible with changing priorities
. Bachelor's Degree in Chemistry or other science-related discipline
. Two years of laboratory experience, preferably in an FDA-regulated laboratory environment
. Empower experience is preferred
Physical/Mental Requirements:
The physical demands described herein are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mobility to work in an office setting, use standard office equipment and stamina to sit for extended periods of time; strength to lift and carry up to 10 pounds; vision to read printed materials and computer screens; and hearing and speech to communicate in person or over the telephone.
Working Environment:
Work is performed in a lab and office setting. Work is subject chemicals, fumes, gasses, noxious odors and related items in a lab setting.
Requirements:Pace® Life Sciences
Pace® makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace® provides professional services to support their operations.
Req Benefits:
Benefits
80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.
Equal Opportunity Employer
Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
