Analytical Stability Data Reviewer

Morrisville, NC 27560

Posted: 07/09/2024 Employment Type: Contract Division: Life Sciences Job Number: JN -072024-19229 State: North Carolina

Job Description

ANALYTICAL 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: Analytical Stability Data Reviewer
Location: Morrisville, NC
Industry: Pharmaceutical
Hours: Shift M-F 8am 5:00pm
Salary: $28/hr.-$33/hr. depending on experience
Employment Type: 6 month contract (Possible Hire)

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 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:
  • Performs parallel review of laboratory documentation and may become qualified to perform technical review of documents for accuracy, completeness, and regulatory compliance
  • May draft technical documents such as methods or certificates of analysis.
  • Trains others on laboratory techniques.
  • Assists in the execution of efficiency improvement project with guidance
  • All other duties as assigned.
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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About Morrisville, NC

Ready to take the next step in your career? Explore our job opportunities in the vibrant area surrounding Morrisville, North Carolina! Nestled in the heart of the Research Triangle Park, this region offers an exceptional blend of bustling tech hubs, picturesque green spaces like Lake Crabtree County Park, and a lively cultural scene boasting the North Carolina Museum of Art and the Duke Energy Center for the Performing Arts. Indulge in the area's diverse culinary scene, catch a game at the PNC Arena, home to the Carolina Hurricanes, or simply relax at Umstead State Park. Embrace the charm and endless growth opportunities that Morrisville and its surroundings have to offer - your dream job could be just a click away!