What are the responsibilities and job description for the Associate Clinical Quality Manager, I 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.
Assists with coordinating quality activities in support of site customers to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management.
Essential Duties and Responsibilities:
Responsible for creating, routing internally and obtaining customer approval of batch records and packaging material and distribution specs. On time and accuracy are essential to the Clinical Services business model as patient supply cannot be compromised.
Assist with performing record reviews of completed orders and orders in process to ensure compliance with cGMP's and customer requirements.
Actively participates and attends conference calls and customer meetings; CPT and other special project meetings for all assigned projects as needed.
Assist as company liaison with customers concerning quality control documentation. Help identify, communicate, track and resolve document related issues with other departments and customers.
Assist with generating and presenting quality related metrics and key performance indicators for team's performance.
Assist with addressing and documenting quality events with Production and Quality teams.
Assist with training, developing, and mentoring new Quality Specialists and Quality Inspectors.
This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position.
Audit participation as needed.
Develops, writes, revises and reviews work practices and forms in accordance with PCI and GMP requirements. Verifies changes adhere with SOP's, WP's and customer requirements.
Serves as company liaison with customers, PCI US internal departments, PCI UK and Qualified Persons (QP's) concerning quality control batch release documentation, investigations, complaints and CAPA's.
Responsible for ensuring CAPA's effectiveness and timeliness.
Writes, coordinates and maintains Quality related investigations, including but not limited to, exception events and customer specific investigations on time and obtaining customer approvals.
Writes and/or reviews Exception Reports for packaging, receiving and distribution. Performs other duties as assigned by site leader.
Special Demands:
Stationary Position: From 1/2 to 3/4 of the day.
Move, Traverse: From 1/4 to 1/2 of the day.
Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.
Install, place, adjust, apply, measure, use, or signal: None.
Ascend/Descend or Work Atop: None.
Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
Communicate or exchange information: 3/4 of the day and up.
Detect, distinguish, or determine: From 1/4 to 1/2 of the day.
On an average day, the individual can expect to move and/or transport up to 10 pounds
between 1/4 and 1/2 of the day.
This position may have the following special vision requirements.
Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception
Ability to focus No Special Vision Requirements
Work Environment:
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
The noise level in the work environment is typically, moderate.
Qualifications:
Required:
Associate's Degree in a related field and/or 1-3 years related experience and/or training.
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of 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 demonstrate attention to detail.
Ability to work independently and/or part of a team.
Ability to hold oneself in a professional manner.
Ability to effectively present information to various people as the job requires.
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.