What are the responsibilities and job description for the Quality Supervisor position at PCI Pharma Services?
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Quality Supervisor is responsible for leading efforts in planning, directing, and coordinating customer focus team Quality activities in order to ensure that the quality of PCI's products are in compliance with customer requirements as well as state and federal regulations. Lead and play an integral part in individual project success and provide PCI a competitive advantage in long-term customer management.
Essential Duties and Responsibilities:
1. Prepares and distributes required documentation for requested production work orders.
2. Perform documentation and records review of completed orders to ensure compliance with cGMP's and customer requirements.
3. Creating and updating batch records, forms and material specifications as well as organizing internal and customer approval of batch records and specifications.
4. Performs and submits batch records, accountability reports and necessary documentation to customers to facilitate product release.
5. Help identify, communicate, track and resolve document related issues with other departments and customers.
6. Function as one of the customer points for comments or questions pertaining to batch documentation.
7. Assist with providing quality related metrics.
8. Performs finished product batch release of approved production lots.
9. Meet with management to address issues or concerns with the batch documentation.
10. Reviews and interprets customer standards, procedures and specifications for dissemination relative to batch records, forms and material specifications. Organize internal and customer approval of batch records and specifications.
11. This position may require overtime and/or weekend work.
12. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
13. Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor.
Qualifications:
Required:
- Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
- College Level Mathematical Skills
- Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
Preferred:
- Ability to effectively present information to various people as the job requires.
- Ability to identify and resolve problems in a timely manner.
- Ability to travel.
Join us and be part of building the bridge between life changing therapies and patients.
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
#LI-LL1
Join us and be part of building the bridge between life changing therapies and patients.
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.