Summarized Purpose:
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
Key responsibilities:
Employee will be expected to participate in all aspects of department visual inspection program, including preparation of the inspection suite, stocking of related supplies, performance of inspection of injectable products, completion of associated logbooks and batch documentation, and storage of finished product.
Individual can pass color-blindness and vision testing (must achieve 20/20 with or without vision correction such as glasses or contact lenses).
Must be able to pass visual appearance testing method competencies within 90 days of hire.
When not inspecting, employee will be asked to complete training in and perform functions in manufacturing operations, which may include vial washing, component rinsing and preparation, Container Closure Integrity testing, and other manufacturing tasks as requested.
Employee will also assist with department consumables storage and stocking programs.
Employee may be asked to perform administrative tasks such as procedure revision, template revision, records filing, records archiving, and other tasks as needed.
All job functions will be performed according to procedure and in accordance with cGMP, Standard Operating Procedures, and CODE safety codes and regulations.
Identifies risks to business for consideration by management.
Assist and contribute to GMP and safety self-inspection activities.
Accountable for delivering innovation in the Clinical Supply Chain to deliver cost savings, reduce risk and improve service.
Accountable for reporting and maintaining metrics as appropriate.
Zero instances of data falsification or data integrity issues by staff.
Employee has basic computer skills including Word, Outlook, and ability to navigate simple website interfaces.
When performing visual inspection, employee will be expected to sit and inspect product for periods of up to one hour with small (5-10 minute) breaks once an hour, for no longer than 8 hours a day.
When performing manufacturing operations, employee will be expected to wear appropriate gowning (scrubs, hair net, beard cover, gloves, safety glasses, safety shoes), stand for periods of time, and operate standard pharmaceutical manufacturing equipment.
Employee must have good hygiene, practice good hand-washing behaviors, and be comfortable frequently using hand sanitizing agents.
When performing manufacturing operations, employee may not wear jewelry, makeup, perfume, nail polish, or have artificial nails. Flat wedding bands and medical alert bracelets are accepted.
Employee may be asked to work occasional overtime hours.
Must be a committed team player prepared to work in and embrace a team-based culture.
Education and Experience:
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Assoc Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2 years)
In some cases, an equivalency, consisting of a combination of appropriate education, training, and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Application of knowledge and leveraging of continuous improvement activities utilizing available tools where applicable that support continued adherence with industry regulations, Global Quality Policies (GQP 3201A and GQP 3201B) and supporting business procedures.
Proactively communicates the status of critical compliance systems support and problem resolution. Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed to appropriate levels of Sterile Ops management.
Applies metric generation and reporting for Sterile Ops led processes.
Leads by example in working collaboratively and embracing CODEs Code of Conduct to effectively implement solutions. Develops and maintains mutually productive relationships in the workplace. Builds and leverages their own networks of expertise formed with other senior internal and external personnel for the benefit of the team.
Leads the identification and implementation of strategies to improve the qualities and efficiencies of Sterile Ops processes, systems and results. Maintains strong systems/processes understanding of current technologies and professional concepts.
Responsible for scheduling and planning work to meet priorities set by CODE. Sets specific daily and weekly priorities to meet timelines. Recommends procedures and policies to supervision.