What are the responsibilities and job description for the PLS QA Specialist II position at Pace Life Sciences?
About Us
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.
Job Description
This is a full-time QA Specialist II position located in Lebanon, NJ, from Monday - Friday, 8 : 00 a.m. to 5 : 00 p.m.
Primary Responsibilities :
- Responsible for assuring that all quality related records generated by the company adhere to a strict review process insuring the integrity of the final report of analysis following all regulatory and company standards.
- Support laboratory activities that require Quality Assurance involvement.
- Assist Management in client communication, client questionnaires and approval of lab equipment activities (IQ, OQ, PQ, PV, PM and calibration documents)
- Prepares or assists in writing, reviewing, approving, and implementing standard operating procedures (SOPs)
- Initiate and review proper change control, deviation, out-of-specification, and investigation documentation when required
- Review instrument qualification and analytical method validation protocols and reports
- Update pertinent logs and tracking systems as they relate to the company's Quality Systems Document Control
- Other duties and responsibilities may be required as needed
Desired Skills :
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 a lab and office setting, use standard office and lab equipment and stamina to sit for extended periods of time; exerting up to 20 pounds of force occasionally and / or up to 10 pounds of force frequently to lift, carry, push, pull or move objects; 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 to chemicals, fumes, gasses, noxious odors, and related items in a lab setting.
Additional Information
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, parental leave, 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.
Pay Range / Compensation Up to $82,000 per year
Work Schedule Monday through Friday, 8 : 00 AM - 5 : 00 PM
Salary : $82,000
