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12 days old

Packaging Supervisor (1st Shift)

Kelly Services
Lansdale, PA 19446
**KellyOCG is hiring a Packaging Supervisor for a long term opportunity direct with a well known sponsor company in West Point PA. This is a 1st shift position (6:30 am - 2 pm). We offer full benefit options under our OCG group.**




**BASIC FUNCTION:**



Responsible for overseeing clinical packaging operations as well as completing compliance and quality-related tasks within the Global Clinical Supplies Packaging group, including personnel scheduling and training, ensuring preparation of investigational drug products meets current quality standards, investigating clinical complaints and deviations, developing corrective/preventive actions, and updating Standard Operating Procedures.



**Duties and Responsibilities (including but not limited to):**




1. Ensure personnel are adequately trained

2. Manage/schedule personnel for GMP activities

3. Oversee and manage the GMP compliance of staff

4. Author SOPs within the functional area

5. Manage the ordering and inventory levels for secondary packaging components

6. Provides Quality oversight to the Packaging area through the following:

7. Perform complaint and deviation investigations with a focus on true root cause, and creation of appropriate CAPA's. Drive CAPA's to closure

8. Ensure clinical supplies are processed according to GMPs and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies.

9. Participate as subject matter expert during internal or external audit from Quality group, safety bodies or regulatory agencies

10. Generate and oversee the change controls necessary for movement or modification to existing packaging equipment

11. Support creative problem solving, provides detailed analysis of issues and anticipates technical problems and obstacles as they relate to clinical supplies and participates in adjustment of logistics pertaining to drug supply. May involve liaison with Global Clinical Supplies or external partner groups

12. Contribute to the Global Clinical Supplies packaging, labeling and distribution strategy through participation in process, providing expert technical review and approval of proposals.

13. May represent Global Clinical Supplies on cross-functional teams or represent Operations group on internal teams as appropriate. Will undertake specific projects within the group on as needed basis





**Education and Work Experience:**




1. Bachelor's degree in life science, or related discipline

2. At least 4 years of experience in the pharmaceutical industry, preferably in a clinical supply related area.

3. Main responsibilities: Writing investigations, CAPAs, SOPs, etc

4. Above average proficiency in Microsoft applications (Word, Excel, PowerPoint)

5. Experience with inventory management systems (e.g. SAP)

6. Knowledge of Supply Chain Management





**Knowledge, Skills, and Abilities:**






1. Problem solving skills, including ability to think critically in addressing issues such as investigations and complaints

2. Detail-orientated.

3. Interpersonal skills in verbal and written communication, ability to negotiate, resolve conflicts and engage in decision making to partner and influence

4. Knowledge of supply chain management including demand planning and drug replenishment procedures

5. Excellent computer skills including Microsoft applications; SAP is highly desirable.

6. Proven organization skills.

7. Strong ability to multi-task.

8. Familiarity with GMP requirements, quality and safety procedures, SOP execution, and right-first-time metrics tracking

9. Ability to follow Standard Operating Procedures (SOP's).

10. Demonstrated high level of initiative and ability to function independently with minimal or no daily supervision.








**Why Kelly** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2020-01-06 Expires: 2020-02-06

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Packaging Supervisor (1st Shift)

Kelly Services
Lansdale, PA 19446

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