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.

Summary of Objective:

Determines and maintains quality standards developed in compliance with current Good Manufacturing Practices, the Company's own Standard Operating Procedures and customer requirements. Provides resolution to quality issues regarding components. Recommends solutions based on SOP / cGMP requirements.

Essential Duties and Responsibilities:

• Coordinates the daily activities of IQA personnel.

• Responsible for overseeing quality improvement processes related to receiving inspection.

• Implements inspection criteria and testing

• Study and standardize departmental work practices to improve quality and efficiencies of subordinates.

• Helps resolve quality related issues with other departments and customers. Motivates, develops and provides continuous training either through the use of departmental work instructions, examination of cGMP's and SOP's, specific customer requirements or by personal instruction.

• Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc.

• Reviews daily paperwork to assure all customer requirements and quality standards have been met and maintained.

• Promotes continuity of shifts through cooperation and communication within as well as with other departments.

• Assist in the performance of monthly internal audits and any necessary corrective action to follow-up

• Trouble-shoot special equipment and software utilized during incoming inspections, i.e. barcode scanners, auto comparators, tridium displays.

• May disposition NMR's.

• Recommend and participate in disciplinary activities of subordinates.

• Maintain testing equipment and supplies needed for the department

• May assist in performing investigations, may write reports, memos, or letters.

• Responsible for technical review of all business critical NMRs and work with Procurement and supplier to resolve issues.

• 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

• Performs other duties as assigned by Manager/Supervisor.

Special Demands:

- Stationary Position: From 1/2 to 3/4 of the day.

- Move, Traverse: From 1/2 to 3/4 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: From 1/2 to 3/4 of the day. - Ascend/Descend or Work Atop: From 1/4 to 1/2 of the day.

- Position self (to) or Move (about or to): From 1/2 to 3/4 of the day. - Communicate or exchange information: 3/4 of the day and up.

- Detect, distinguish, or determine: 3/4 of the day and up. On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 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 performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 1/2 to 3/4 of the day.

* Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.

* Work near moving mechanical parts for 1/4 to 1/2 of the day. The noise level in the work environment is typically, moderate.

Qualifications:

Required:

- Bachelor's Degree in a related field and/or 1-5 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.

- High Standard of Report Writing

Preferred:

- Ability to effectively present information to various people as the job requires.

- Ability to work independently and/or part of a team.

- Ability to display a willingness to make decisions.
- Ability to display excellent time management skills.

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.