Location
Agawam, MA | United States
Job description
Company Information
You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
- engage in work that matters to our customers and the patients they serve
- learn new skills and enjoy new experiences in an engaging and safe environment
- strengthen connections with coworkers and the community
We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more!
Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
The Log-in Clerk provides support for all lab services regarding sample management coordination and documentation. Performs miscellaneous job-related duties as assigned and cross trains to be able to back up other team members. All work is conducted per SOPs and GMP practices.
Hours for this position are from 10:30 AM - 7:00 PM, Monday-Friday Responsibilities
- Accepts and takes responsibility for all incoming samples received by outside and internal courier services.
- Reviews the received samples, test request forms (TRF), and all associated documentation for discrepancies. Responsible for resolving incomplete paperwork or discrepancies with the client or via the Sales Department.
- Responsible for the generation of the lab services work order utilizing the information provided by the client and the information documented during the receipt and sample review process.
- Responsible for the labeling and proper storage of client samples/paperwork in a manner that eliminates product traceability issues.
- Assists in the distribution of client samples to the analysts. Responsible for sending subcontract samples along with the appropriate documentation.
- Responsible for disposition of samples as requested by clients and for distributing example samples to the appropriate supervisor.
- Responsible for maintaining the client sample quarantine area in accordance with current Good Manufacturing Practices (cGMP).
- Responsible for communicating sample receipt information with the laboratories for STAT testing and samples requiring immediate testing (e.g. water and BIs samples).
- May be asked to perform additional duties in assigned and unassigned areas.
Qualifications/Skills
- Basic understanding cGMP requirements for role
- Good computer skills, including Microsoft Word, Excel, and Outlook, and Internet.
- Understands the importance of following all company SOPs
- Basic office and organizational skills, filing, setup up and maintain systems to support the organization
- Knowledge of business English, correspondence formats, spelling and grammar sufficient to proofread materials and ensure the accuracy and completeness of written communications.
- Detail-oriented, organized and applies effective time management skills in order to meet all deadlines. Able to successfully prioritize and manage multiple tasks and numerous projects in a fast-paced environment.
- Promotes a safe work environment. Ability to wear Personal Protective Equipment (PPE). Understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled substances.
- Ability to conduct routine in-process testing and visual inspections and identify out-of-specification conditions.
- Ability to work in a regulated environment (FDA/DEO/OSHA) and strictly follow procedures.
- Effectively communicates both verbally and in writing.
- Ability to read and comprehend detailed written instructions.
- Ability to clearly and concisely document all work activities in a timely manner utilizing existing forms and records. Writes legibly.
- Perform basic math functions to include product accountability and material adjustment calculations and rounding. Basic computer skills.
- Ability to move materials throughout facility using appropriate methods and equipment.
- Operate machinery and read process control instruments to ensure proper operation. Identify operations problems when they occur.
- Must have the ability to work overtime when required.
- Must adhere to attendance policy. Expected to arrive for shift on time and contact management immediately if unable to attend work for any period of time.
- Ability to work effectively within a team environment.
Education, Experience & Licensing Requirements
- High school diploma or equivalent
- 1+ years of experience in a regulated environment
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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Supervision Received: Direct
Works under direct supervision. Relies on experience and judgment to plan and accomplish goals within defined procedures and practices. Seeks management direction for problems of diverse scope. Travel: Not Applicable Physical and Environmental Demands:
Travel: Not Applicable
Physical Demands :
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Environment and Protective Equipment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.
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