Stability Data Reviewer

STABILITY DATA REVIEWER

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

• Title: Stability Data Reviewer
• Location: Morrisville, NC.
• Industry: Pharmaceutical
• Hours: Shift M-F 8am 5:00pm
• Salary: 28-33$/h (Paid Weekly - Benefits Available)
• Employment Type: 6 months (Possible Hire)

Department Overview:
The QC team is responsible for the support of pharmaceutical testing in the form of API, Finished Product, Stability, Raw Materials and Components associated with external customers including Client sites.

Job Overview:
The Analytical Stability groups at Morrisville are responsible for the support of pharmaceutical testing of a range of dosage forms both directly with customers and in collaboration with other facilities. Testing supports stability for pre-commercial and commercial drug products.

Job Summary:
The Stability Data Reviewer II position under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians/assistants. Comply with divisional and site Environmental Health and Safety requirements.

Specific Skills, Duties, Activities, and Responsibilities

Education and Experience:
Master s degree and 0-2 years related experience;
Bachelor s degree and 3-5 years related experience; or
Associate s degree and >6 years related experience or equivalent education, experience, and training

Knowledge, Skills and Abilities:
All employees must receive training on the fundamental principles of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity, and employee conduct as a condition for performing GxP activities.
All employees performing GxP activites must be trained, at least annually, on the requirements established for GxP Documentation and Data Integrity.
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
Ability to learn and retain technical information
Proactively address work issues at both an individual level and a team level
Develop and review procedures or methods of moderate complexity with high quality
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
Mathematical and scientific reasoning ability
Basic understanding of instrument operations and troubleshooting skills in multiple techniques
Ability to identify aberrant/out of spec data and limited interpretation of data expected
Excellent written and verbal communications skills with internal and external customers
Lead by example according to values and culture
Demonstrated ability to lead small team projects
Recognizes unmet needs within department
Strategy is focused on personal time management and efficiency
Well organized with ability to multitask
Ability to work effectively under pressure to meet deadlines
Has applied knowledge of the principles and concepts of a discipline.
Applies technical and functional knowledge to job related duties on most projects/ assignments within own group/project team.
Propose deviations from established procedures and methods based upon sound judgment.
May contribute material to publications and/or external presentation

Physical Requirements:
On an average 8 hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds
Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
May require the use of a respirator

Working Conditions and Environment:
This position will be stationed in an office and laboratory environment involving work near moving/mechanical parts; working around various chemicals including biologics, active pharmaceuticals, beta-lactams and radioactive materials; and other conditions reasonably expected due to the nature of the work required
Position may require domestic or international travel
Flexibility required to work outside normal working hours of 8:00 a.m. 5:00 p.m

EOE/ADA
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