PCI Pharma Services Quality Assurance Specialist Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their 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.This position is responsible for performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with applicable Quality Assurance (QA) and regulatory requirements, including assisting with audits, training programs, and documentation review in support of GMP operations. Promotes a compliant cGMP environment and follows SOPs. Provides quality support for investigations related to quality events associated with GMP manufacturing operations. Generates documentation and ensures completeness for batch disposition and batch record packet assembly. Ability to work independently, within prescribed guidelines, and as a team member. Leads projects and trains junior staff.
Hours: 1st Shift
Essential Job Functions:- Assists in regular follow ups with end users to ensure timely completion of open investigations and investigation activities.
- Assist in ensuring the adequacy of investigations performed in relation to manufactured drug product and drug substance to support the batch release process.
- Provides quality support in the review and approval of quality reports including deviations, OOSs, complaints, OOTIs, SCARs, and corrective and preventive actions (CAPAs)
- Generates and compiles lot file review documentation for batch disposition.
- Updates lot status in ERP system.
- Responsible for equipment inductions, revisions and record maintenance within the electronic
- Technical Quality review of validation protocols and reports.
- Performs logbook documentation audits for cGMP regulated logs and SOPs.
- Creates, revises and approves procedures.
- Performs the review of equipment and facility related Change Control
with internal, client and regulatory audits.
Assists with the generation of department metrics.
Assists with developing recommendations for continuous improvement projects.
Assists in the review and approval of production batch records and associated data for product disposition.
Assists in the review and approval of controlled documents including standard operating procedures, protocols, and reports.
Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Fosters a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Education and Experience:
High School Diploma or equivalent. Bachelor's degree strongly preferred in a Life Sciences discipline or equivalent.
Minimum of three to five (3-5) years of relevant GMP experience in documentation, QA on the floor, manufacturing, or equivalent.
Knowledge of cGMP regulations and good documentation practices preferred.
Strong organizational and analytical skills.
Must be familiar with Microsoft Office
hiring rate for this position is $29.65 - $33.36/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).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
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.
