What are the responsibilities and job description for the PLS QA Specialist II - Lebanon, NJ position at Pace Analytical Services, LLC?
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.
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 ensuring 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 of 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:
- A Bachelor's degree in Chemistry or other science-related disciplines.
- Previous experience (3-6 years) working in a Pharmaceutical QA environment.
- Knowledge of various regulatory systems and guidelines is ideal (FDA and EU, cGMP, etc.)
- Must be detail-oriented, organized, and possess the ability to be flexible to meet the needs of technical employees across multiple departments
- Ability to work independently or as part of a team
- Must possess strong interpersonal skills and have the proven ability to communicate with employees/customers/clients in both oral and written form, fluent in the English language
- Willingness to learn and expand their knowledge and technical expertise in a fast-paced environment
- Strong computer skills; emphasis on Microsoft Excel and Word
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, gases, noxious odors, and related items in a lab setting.
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.
Pace Analytical is an equal opportunity employer.
Salary : $82,000
