Clinical Quality Inspector

PCI TRGR Penn Pharmaceutical Services Ltd; Bridgewater (MA); On-site; USD 40,000 - 60,000; Full time

Job summary

PCI Pharma Services in Massachusetts, Bridgewater, is seeking diligent staff for clinical packaging and quality inspection roles. You will select products for tests, and perform receiving, in-process, finished goods and distribution inspections, ensuring strict adherence to cGMP and GCP.

Documentation accuracy is essential. The role requires precision, attention to detail, and the ability to work across multiple packaging lines, with potential overtime or weekend work.

Qualifications

• Basic mathematical skills for testing and data recording.
• Ability to perform basic computer tasks and operate common programs.
• Ability to read standard items addressed to general readers.

Responsibilities

• Selects products for tests and specified stages in production.
• Performs receiving, in-process, finished goods and distribution inspection.
• Maintains clinical blinding requirements and ensures documentation accuracy.
• Records test data using statistical quality control procedures.
• May participate on Customer Project/Improvement teams.

Skills

Basic Math

Computer Skills

Reading Skills

Reasoning

Attention to detail

Teamwork

Job description

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. Selects products for tests and specified stages in production. Performs receiving, in-process, finished goods and distribution inspection as required. Ensures work is consistent between work orders to maintain clinical blinding requirements. Works effectively in a clinical packaging environment that utilizes serialized kit numbers, where one packaging lot is made up of multiple individual packaging lots. Manages multiple clinical production lines at the same time, with various types of work order activity. Completes documentation of paperwork to ensure accuracy and correctness. May oversee pest control inspections. Interprets formulas to arrive as specified quality and reliability standards. May participate on Customer Project/Improvement teams. Records tests data, using statistical quality control procedures. Inspects and ships samples to customers. Supports accurate storage of retain components and/or finished goods.

PAPR requirements 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

• Stationary Position: Under a 1/4 of the day.
• Move, Traverse: 3/4 of the day and up.
• Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.
• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
• Ascend/Descend or Work Atop: From 1/2 to 3/4 of the day.
• Position self (to) or Move (about or to): 3/4 of the day and up.
• 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 between 1/2 and 3/4 of the day.

Special Vision Requirements

• Close Vision
• Distance Vision
• Color Vision
• Peripheral Vision
• Depth Perception
• Ability to focus
• No Special Vision Requirements

Environmental Conditions

Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 3/4 of the day and up. Work near moving mechanical parts for 1/2 to 3/4 of the day. The noise level in the work environment is typically, loud.

Required

• Skills testing requirements met at approved grade level for position
• Basic Mathematical Skills
• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
• Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations.
• Ability to read various types of standard items addressed to general readers.
• Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form.
• Ability to deal with problems that involve several concrete variables in standardized situations.

Preferred

• Ability to demonstrate attention to detail.
• Ability to work independently and/or part of a team.
• Ability to effectively present information to various people as the job requires.
• Ability to adapt to changing work environments.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Regional Compliance

IF YOU ARE A RESIDENT OF MASSACHUSETTS OR APPLYING FOR A JOB IN MASSACHUSETTS PLEASE READ: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.