Finish Line Staffing Services Published: October 14, 2019
DUTIES & RESPONSIBLITIES
- Prepares for production by reviewing SOPs and batch records.
- Prepare equipment and filling rooms by performing minor/major cleanings as needed
- Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures
- Set-up, operate and calibrate equipment necessary for different products; operate packaging equipment including powder fillers, cappers, labelers, and induction sealers, etc.
- Assist with prescribed preventative maintenance on machines as required per P.M. program
- Assist the Quality Unit with Quality Control functions such as inspection and AQL
- Assist with Validation activities of equipment including, but not limited to reviewing, writing, and revising procedures and processes.
- Operate and perform daily inspection and maintenance of the waste water system, DI water system and compressed air system
- Keeps equipment operating by following operating instructions; troubleshoot line stoppages; calling for repairs
- Documents production by completing applicable forms, reports, logs, and records equipment and batches
- Inventory materials for packaging prior to starting, during production, and at completion of the process
- Assemble kit components according to established procedures into appropriate sub-assemblies or finished box
- Communicate and document status of processes, products, and equipment
- Communicate the status of production operations and bring deviations to the attention of supervisor
- Updates job knowledge by participating in training opportunities
- Participate in process improvements under the guidance of a supervisor
- Help in the training of co-workers in accordance with established training programs
- Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job requirements.
- Assist with special projects as needed.
PREPARATION, TRAINING & EXPERIENCE
- High School Diploma is desired. Associates degree or higher in a relevant discipline is a plus
- Science background is a plus
- Must be at least 18 years of age.
- Experience in pharmaceutical, medical device, or cGMP laboratories with emphasis in assembly line/packaging preferred.
- Experience in product filling, audits, validation assistance, maintaining cGMP as well as participating in responses to internal and external audits of the operation is desirable.
- A solid foundation of basic mathematics for reconciliation purposes
- Familiarity with basic regulatory guidelines dealing with parental drug, aseptic or non-aseptic manufacturing is desirable
- Self-motivated, reliable; follows instructions without error and can perform duties with minimal guidance
- Familiarity with cGMP requirements, SOPs and gowning experience a plus
- Understanding of basic contamination and hygiene
- Strong commitment to excellence and quality with a positive working attitude
- Knowledge of Production Equipment, Process Techniques and Unit Operations
- Documentation skills
- Ability to learn new skills quickly
- Ability to work flexible schedule and overtime as required.