QA Associate I - Operations
Company: PCI Pharma Services
Location: Bedford
Posted on: April 16, 2024
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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.
The Quality Associate I - Operations is responsible to provide QA
support real-time for GMP Manufacturing of drug product.
Responsibilities include providing QA on the Floor oversight of
manufacturing including observing critical processes and performing
AQL visual inspection, executed GMP documentation review and
supporting other QA functions as needed. Real time continuous
monitoring of manufacturing related systems and processes to ensure
compliance with applicable regulatory and industry standards,
needed quality improvements, and safety/efficacy for phase
appropriate GMP manufacture of drug products.
JOB DUTIES
--- Performs QA On-the-Floor activities supporting client projects,
including room release, auditing critical processes, reviewing
documentation in real time, and resolving issues that occur during
manufacturing
--- Perform audits of manufacturing and support areas, including
in-process batch record review for adherence to internal procedures
and Good Documentation Practices
--- Review executed Manufacturing Batch Records and supporting
documentation for completeness, accuracy and compliance
--- Support the evaluation and lot disposition of intermediates,
finish bulk drug substance and drug product
--- Act as first responder for on the floor quality issues in a
timely manner, documentation of all events/investigations and
required immediate corrective actions
--- May participate in root cause analysis using methodologies,
such as: fishbone, 5 whys, etc.
--- Act as QA reviewer for deviations and CAPA issuance; with
limited approval authority as designated by QA Management
--- Perform Acceptable Quality Limit (AQL) visual inspection of
drug product
--- Participate in SOP revision as it pertains to process
improvements
--- Participate in site quality and process improvement
initiatives. Represent QA on project teams and represent QA
perspective as necessary
--- Guides personnel indirectly and directly involved in GMP
operations pertaining to cGMP compliance, internal procedures,
regulatory requirements and industry best practices
PROFESSIONAL SKILLS
--- Exceptional organizational skills and attention to detail
--- Ability to make risk based decisions and resolve issues with
minimal guidance
--- Excellent interpersonal skills and the ability to communicate
well orally and in writing
--- Proficiency in MS Office including Word, and Excel
--- Excellent verbal and written communication skills required
EXPERIENCE
--- Exposure to RCA, technical writing, and working with quality
related investigations
--- Exposure to lean operation excellence highly desirable
--- Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820)
and some experience working with international regulations such as
ICH
--- Knowledge and ability to apply basic scientific principles to
solve operational, as well as routine quality tasks
--- Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.)
and familiarity with ICH Q9 preferred
The above statements are intended to describe the general nature
and level of work being performed by people assigned to this
classification. They are
not intended to be construed as an exhaustive list of all
responsibilities, duties and skills required of personnel so
classified.
EDUCATION
--- Bachelor's Degree in a relevant scientific discipline preferred
with a minimum of 0-2 years of pharmaceutical or biotech industry
experience with 1+ years of experience in a QA Operations role
supporting late stage clinical and/or commercial production
preferred
--- ASQ certification preferred
QUALITIES
--- Ability to work in a dynamic, fast paced work environment
--- Honesty, integrity, respect and courtesy with all
colleagues
--- Creative with the ability to work with minimal supervision and
balanced with independent thinking
--- Resilient through operational and organizational change
PHYSICAL REQUIREMENTS & MENTAL DEMANDS
--- Frequent reading, writing, and verbal communication
--- Must be able to travel between multiple local production
facilities
--- Able to translate ideas to actual concepts and processes
--- Proven ability to manage multiple projects (duties)
simultaneously
--- Able to work in a highly complex environment with competing
demands and priorities
COMMUNICATIONS & CONTACTS
--- Cross functional staff, members of management, internal and
external clients, members of the Quality organization
TRAVEL
---
#LI-LL1
Join us and be part of building the bridge between life changing
therapies and patients. Let's talk future (https://pci.com/)
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.
PCI Pharma Services is an Equal Opportunity
Employer/Vet/Disabled
Keywords: PCI Pharma Services, New England , QA Associate I - Operations, Other , Bedford, Northeast
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